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Doug Brunk is a San Diego-based award-winning reporter who began covering health care in 1991. Before joining the company, he wrote for the health sciences division of Columbia University and was an associate editor at Contemporary Long Term Care magazine when it won a Jesse H. Neal Award. His work has been syndicated by the Los Angeles Times and he is the author of two books related to the University of Kentucky Wildcats men's basketball program. Doug has a master’s degree in magazine journalism from the S.I. Newhouse School of Public Communications at Syracuse University. Follow him on Twitter @dougbrunk.
Hormone Treatment Associated With Better Kidney Function
SAN DIEGO – The use of hormone therapy was associated with a lower urine albumin-to-creatinine ratio and a decreased risk of albuminuria, results from a cross-sectional study suggest.
“This may be useful information for providers taking care of menopausal women who are considering the use of hormone therapy for vasomotor symptoms and are worried about the systemic effects of these medications,” lead study author Dr. Andrea G. Kattah said in an interview after the annual meeting of the American Society of Nephrology. “Though our data only show an association and not cause and effect, hormone therapy is associated with better kidney function in this study.”
Results from many animal studies suggest that estrogen can have beneficial effects on the kidneys, noted Dr. Kattah, who conducted the research with Dr. Vesna D. Garovic and colleagues in the division of hypertension and nephrology at the Mayo Clinic, Rochester, Minn.
“In addition, in human studies of chronic kidney disease, premenopausal women tend to have slower progression of kidney disease than men,” she said. “Studies on the effects of hormone therapy on kidney function in women have had variable results. We wanted to look at the association of hormone therapy and renal function in a large, multiethnic cohort with well-defined health conditions that may confound the relationship between hormone therapy and renal disease.”
Study participants included 2,217 women enrolled in the Family Blood Pressure Program, a multinetwork effort to study the genetics of hypertension. During a study visit between 2000 and 2004, the women completed questionnaires about medical history, menopausal status, and use of hormone therapy (HT) in the past month. Clinicians also took their blood pressure, measured their body mass index, and drew blood to determine levels of serum creatinine and urine albumin-to-creatinine ratio (UACR).
Of the 2,217 women, 673 were on HT and 1,544 were not, and their mean ages were 60 years and 63 years, respectively.
In unadjusted analysis, Dr. Kattah and her associates found that UACR was significantly lower in those on HT, compared with those who were not (3.5 mg/g creatinine vs. 5.2 mg/g creatinine, respectively, P less than .001), as was the number of women with an estimated glomerular filtration rate (eGFR) of less than 60 mL/min per 1.73 m2 (7% vs. 10%, P = .003).
After adjusting for renal and cardiovascular risk factors including age, race, smoking, diabetes, hypertension, and family history of hypertension, the use of HT was still significantly associated with a lower UACR and decreased risk of microalbuminuria (odds ratio, 0.61). The association between HT and eGFR of less than 60 mL/min per 1.73 m2 was no longer significant after adjustment, but there was a trend toward higher eGFR and fewer women with an eGFR of less than 60 mL/min per 1.73 m2 among those on HT.
“Not surprisingly, the women taking hormone therapy were different than those who were not, and they generally had fewer health problems, such as diabetes and hyperlipidemia,” Dr. Kattah said. “However, after taking these differences into account in our models, we still found a significant decrease in the risk of having microalbuminuria in those on hormone therapy.”
Dr. Kattah acknowledged certain limitations of the study, including the fact that its design is “cross-sectional and cannot answer the question of whether or not hormone therapy can improve kidney function.
In addition, “we do not have data on how long women were taking hormone therapy, which other studies have suggested is an important factor.”
The researchers reported having no financial disclosures.
SAN DIEGO – The use of hormone therapy was associated with a lower urine albumin-to-creatinine ratio and a decreased risk of albuminuria, results from a cross-sectional study suggest.
“This may be useful information for providers taking care of menopausal women who are considering the use of hormone therapy for vasomotor symptoms and are worried about the systemic effects of these medications,” lead study author Dr. Andrea G. Kattah said in an interview after the annual meeting of the American Society of Nephrology. “Though our data only show an association and not cause and effect, hormone therapy is associated with better kidney function in this study.”
Results from many animal studies suggest that estrogen can have beneficial effects on the kidneys, noted Dr. Kattah, who conducted the research with Dr. Vesna D. Garovic and colleagues in the division of hypertension and nephrology at the Mayo Clinic, Rochester, Minn.
“In addition, in human studies of chronic kidney disease, premenopausal women tend to have slower progression of kidney disease than men,” she said. “Studies on the effects of hormone therapy on kidney function in women have had variable results. We wanted to look at the association of hormone therapy and renal function in a large, multiethnic cohort with well-defined health conditions that may confound the relationship between hormone therapy and renal disease.”
Study participants included 2,217 women enrolled in the Family Blood Pressure Program, a multinetwork effort to study the genetics of hypertension. During a study visit between 2000 and 2004, the women completed questionnaires about medical history, menopausal status, and use of hormone therapy (HT) in the past month. Clinicians also took their blood pressure, measured their body mass index, and drew blood to determine levels of serum creatinine and urine albumin-to-creatinine ratio (UACR).
Of the 2,217 women, 673 were on HT and 1,544 were not, and their mean ages were 60 years and 63 years, respectively.
In unadjusted analysis, Dr. Kattah and her associates found that UACR was significantly lower in those on HT, compared with those who were not (3.5 mg/g creatinine vs. 5.2 mg/g creatinine, respectively, P less than .001), as was the number of women with an estimated glomerular filtration rate (eGFR) of less than 60 mL/min per 1.73 m2 (7% vs. 10%, P = .003).
After adjusting for renal and cardiovascular risk factors including age, race, smoking, diabetes, hypertension, and family history of hypertension, the use of HT was still significantly associated with a lower UACR and decreased risk of microalbuminuria (odds ratio, 0.61). The association between HT and eGFR of less than 60 mL/min per 1.73 m2 was no longer significant after adjustment, but there was a trend toward higher eGFR and fewer women with an eGFR of less than 60 mL/min per 1.73 m2 among those on HT.
“Not surprisingly, the women taking hormone therapy were different than those who were not, and they generally had fewer health problems, such as diabetes and hyperlipidemia,” Dr. Kattah said. “However, after taking these differences into account in our models, we still found a significant decrease in the risk of having microalbuminuria in those on hormone therapy.”
Dr. Kattah acknowledged certain limitations of the study, including the fact that its design is “cross-sectional and cannot answer the question of whether or not hormone therapy can improve kidney function.
In addition, “we do not have data on how long women were taking hormone therapy, which other studies have suggested is an important factor.”
The researchers reported having no financial disclosures.
SAN DIEGO – The use of hormone therapy was associated with a lower urine albumin-to-creatinine ratio and a decreased risk of albuminuria, results from a cross-sectional study suggest.
“This may be useful information for providers taking care of menopausal women who are considering the use of hormone therapy for vasomotor symptoms and are worried about the systemic effects of these medications,” lead study author Dr. Andrea G. Kattah said in an interview after the annual meeting of the American Society of Nephrology. “Though our data only show an association and not cause and effect, hormone therapy is associated with better kidney function in this study.”
Results from many animal studies suggest that estrogen can have beneficial effects on the kidneys, noted Dr. Kattah, who conducted the research with Dr. Vesna D. Garovic and colleagues in the division of hypertension and nephrology at the Mayo Clinic, Rochester, Minn.
“In addition, in human studies of chronic kidney disease, premenopausal women tend to have slower progression of kidney disease than men,” she said. “Studies on the effects of hormone therapy on kidney function in women have had variable results. We wanted to look at the association of hormone therapy and renal function in a large, multiethnic cohort with well-defined health conditions that may confound the relationship between hormone therapy and renal disease.”
Study participants included 2,217 women enrolled in the Family Blood Pressure Program, a multinetwork effort to study the genetics of hypertension. During a study visit between 2000 and 2004, the women completed questionnaires about medical history, menopausal status, and use of hormone therapy (HT) in the past month. Clinicians also took their blood pressure, measured their body mass index, and drew blood to determine levels of serum creatinine and urine albumin-to-creatinine ratio (UACR).
Of the 2,217 women, 673 were on HT and 1,544 were not, and their mean ages were 60 years and 63 years, respectively.
In unadjusted analysis, Dr. Kattah and her associates found that UACR was significantly lower in those on HT, compared with those who were not (3.5 mg/g creatinine vs. 5.2 mg/g creatinine, respectively, P less than .001), as was the number of women with an estimated glomerular filtration rate (eGFR) of less than 60 mL/min per 1.73 m2 (7% vs. 10%, P = .003).
After adjusting for renal and cardiovascular risk factors including age, race, smoking, diabetes, hypertension, and family history of hypertension, the use of HT was still significantly associated with a lower UACR and decreased risk of microalbuminuria (odds ratio, 0.61). The association between HT and eGFR of less than 60 mL/min per 1.73 m2 was no longer significant after adjustment, but there was a trend toward higher eGFR and fewer women with an eGFR of less than 60 mL/min per 1.73 m2 among those on HT.
“Not surprisingly, the women taking hormone therapy were different than those who were not, and they generally had fewer health problems, such as diabetes and hyperlipidemia,” Dr. Kattah said. “However, after taking these differences into account in our models, we still found a significant decrease in the risk of having microalbuminuria in those on hormone therapy.”
Dr. Kattah acknowledged certain limitations of the study, including the fact that its design is “cross-sectional and cannot answer the question of whether or not hormone therapy can improve kidney function.
In addition, “we do not have data on how long women were taking hormone therapy, which other studies have suggested is an important factor.”
The researchers reported having no financial disclosures.
AT KIDNEY WEEK 2015
Hormone treatment associated with better kidney function
SAN DIEGO – The use of hormone therapy was associated with a lower urine albumin-to-creatinine ratio and a decreased risk of albuminuria, results from a cross-sectional study suggest.
“This may be useful information for providers taking care of menopausal women who are considering the use of hormone therapy for vasomotor symptoms and are worried about the systemic effects of these medications,” lead study author Dr. Andrea G. Kattah said in an interview after the annual meeting of the American Society of Nephrology. “Though our data only show an association and not cause and effect, hormone therapy is associated with better kidney function in this study.”
Results from many animal studies suggest that estrogen can have beneficial effects on the kidneys, noted Dr. Kattah, who conducted the research with Dr. Vesna D. Garovic and colleagues in the division of hypertension and nephrology at the Mayo Clinic, Rochester, Minn.
“In addition, in human studies of chronic kidney disease, premenopausal women tend to have slower progression of kidney disease than men,” she said. “Studies on the effects of hormone therapy on kidney function in women have had variable results. We wanted to look at the association of hormone therapy and renal function in a large, multiethnic cohort with well-defined health conditions that may confound the relationship between hormone therapy and renal disease.”
Study participants included 2,217 women enrolled in the Family Blood Pressure Program, a multinetwork effort to study the genetics of hypertension. During a study visit between 2000 and 2004, the women completed questionnaires about medical history, menopausal status, and use of hormone therapy (HT) in the past month. Clinicians also took their blood pressure, measured their body mass index, and drew blood to determine levels of serum creatinine and urine albumin-to-creatinine ratio (UACR).
Of the 2,217 women, 673 were on HT and 1,544 were not, and their mean ages were 60 years and 63 years, respectively.
In unadjusted analysis, Dr. Kattah and her associates found that UACR was significantly lower in those on HT, compared with those who were not (3.5 mg/g creatinine vs. 5.2 mg/g creatinine, respectively, P less than .001), as was the number of women with an estimated glomerular filtration rate (eGFR) of less than 60 mL/min per 1.73 m2 (7% vs. 10%, P = .003).
After adjusting for renal and cardiovascular risk factors including age, race, smoking, diabetes, hypertension, and family history of hypertension, the use of HT was still significantly associated with a lower UACR and decreased risk of microalbuminuria (odds ratio, 0.61). The association between HT and eGFR of less than 60 mL/min per 1.73 m2 was no longer significant after adjustment, but there was a trend toward higher eGFR and fewer women with an eGFR of less than 60 mL/min per 1.73 m2 among those on HT.
“Not surprisingly, the women taking hormone therapy were different than those who were not, and they generally had fewer health problems, such as diabetes and hyperlipidemia,” Dr. Kattah said. “However, after taking these differences into account in our models, we still found a significant decrease in the risk of having microalbuminuria in those on hormone therapy.”
Dr. Kattah acknowledged certain limitations of the study, including the fact that its design is “cross-sectional and cannot answer the question of whether or not hormone therapy can improve kidney function.
In addition, “we do not have data on how long women were taking hormone therapy, which other studies have suggested is an important factor.”
The researchers reported having no financial disclosures.
SAN DIEGO – The use of hormone therapy was associated with a lower urine albumin-to-creatinine ratio and a decreased risk of albuminuria, results from a cross-sectional study suggest.
“This may be useful information for providers taking care of menopausal women who are considering the use of hormone therapy for vasomotor symptoms and are worried about the systemic effects of these medications,” lead study author Dr. Andrea G. Kattah said in an interview after the annual meeting of the American Society of Nephrology. “Though our data only show an association and not cause and effect, hormone therapy is associated with better kidney function in this study.”
Results from many animal studies suggest that estrogen can have beneficial effects on the kidneys, noted Dr. Kattah, who conducted the research with Dr. Vesna D. Garovic and colleagues in the division of hypertension and nephrology at the Mayo Clinic, Rochester, Minn.
“In addition, in human studies of chronic kidney disease, premenopausal women tend to have slower progression of kidney disease than men,” she said. “Studies on the effects of hormone therapy on kidney function in women have had variable results. We wanted to look at the association of hormone therapy and renal function in a large, multiethnic cohort with well-defined health conditions that may confound the relationship between hormone therapy and renal disease.”
Study participants included 2,217 women enrolled in the Family Blood Pressure Program, a multinetwork effort to study the genetics of hypertension. During a study visit between 2000 and 2004, the women completed questionnaires about medical history, menopausal status, and use of hormone therapy (HT) in the past month. Clinicians also took their blood pressure, measured their body mass index, and drew blood to determine levels of serum creatinine and urine albumin-to-creatinine ratio (UACR).
Of the 2,217 women, 673 were on HT and 1,544 were not, and their mean ages were 60 years and 63 years, respectively.
In unadjusted analysis, Dr. Kattah and her associates found that UACR was significantly lower in those on HT, compared with those who were not (3.5 mg/g creatinine vs. 5.2 mg/g creatinine, respectively, P less than .001), as was the number of women with an estimated glomerular filtration rate (eGFR) of less than 60 mL/min per 1.73 m2 (7% vs. 10%, P = .003).
After adjusting for renal and cardiovascular risk factors including age, race, smoking, diabetes, hypertension, and family history of hypertension, the use of HT was still significantly associated with a lower UACR and decreased risk of microalbuminuria (odds ratio, 0.61). The association between HT and eGFR of less than 60 mL/min per 1.73 m2 was no longer significant after adjustment, but there was a trend toward higher eGFR and fewer women with an eGFR of less than 60 mL/min per 1.73 m2 among those on HT.
“Not surprisingly, the women taking hormone therapy were different than those who were not, and they generally had fewer health problems, such as diabetes and hyperlipidemia,” Dr. Kattah said. “However, after taking these differences into account in our models, we still found a significant decrease in the risk of having microalbuminuria in those on hormone therapy.”
Dr. Kattah acknowledged certain limitations of the study, including the fact that its design is “cross-sectional and cannot answer the question of whether or not hormone therapy can improve kidney function.
In addition, “we do not have data on how long women were taking hormone therapy, which other studies have suggested is an important factor.”
The researchers reported having no financial disclosures.
SAN DIEGO – The use of hormone therapy was associated with a lower urine albumin-to-creatinine ratio and a decreased risk of albuminuria, results from a cross-sectional study suggest.
“This may be useful information for providers taking care of menopausal women who are considering the use of hormone therapy for vasomotor symptoms and are worried about the systemic effects of these medications,” lead study author Dr. Andrea G. Kattah said in an interview after the annual meeting of the American Society of Nephrology. “Though our data only show an association and not cause and effect, hormone therapy is associated with better kidney function in this study.”
Results from many animal studies suggest that estrogen can have beneficial effects on the kidneys, noted Dr. Kattah, who conducted the research with Dr. Vesna D. Garovic and colleagues in the division of hypertension and nephrology at the Mayo Clinic, Rochester, Minn.
“In addition, in human studies of chronic kidney disease, premenopausal women tend to have slower progression of kidney disease than men,” she said. “Studies on the effects of hormone therapy on kidney function in women have had variable results. We wanted to look at the association of hormone therapy and renal function in a large, multiethnic cohort with well-defined health conditions that may confound the relationship between hormone therapy and renal disease.”
Study participants included 2,217 women enrolled in the Family Blood Pressure Program, a multinetwork effort to study the genetics of hypertension. During a study visit between 2000 and 2004, the women completed questionnaires about medical history, menopausal status, and use of hormone therapy (HT) in the past month. Clinicians also took their blood pressure, measured their body mass index, and drew blood to determine levels of serum creatinine and urine albumin-to-creatinine ratio (UACR).
Of the 2,217 women, 673 were on HT and 1,544 were not, and their mean ages were 60 years and 63 years, respectively.
In unadjusted analysis, Dr. Kattah and her associates found that UACR was significantly lower in those on HT, compared with those who were not (3.5 mg/g creatinine vs. 5.2 mg/g creatinine, respectively, P less than .001), as was the number of women with an estimated glomerular filtration rate (eGFR) of less than 60 mL/min per 1.73 m2 (7% vs. 10%, P = .003).
After adjusting for renal and cardiovascular risk factors including age, race, smoking, diabetes, hypertension, and family history of hypertension, the use of HT was still significantly associated with a lower UACR and decreased risk of microalbuminuria (odds ratio, 0.61). The association between HT and eGFR of less than 60 mL/min per 1.73 m2 was no longer significant after adjustment, but there was a trend toward higher eGFR and fewer women with an eGFR of less than 60 mL/min per 1.73 m2 among those on HT.
“Not surprisingly, the women taking hormone therapy were different than those who were not, and they generally had fewer health problems, such as diabetes and hyperlipidemia,” Dr. Kattah said. “However, after taking these differences into account in our models, we still found a significant decrease in the risk of having microalbuminuria in those on hormone therapy.”
Dr. Kattah acknowledged certain limitations of the study, including the fact that its design is “cross-sectional and cannot answer the question of whether or not hormone therapy can improve kidney function.
In addition, “we do not have data on how long women were taking hormone therapy, which other studies have suggested is an important factor.”
The researchers reported having no financial disclosures.
AT KIDNEY WEEK 2015
Key clinical point: Women using hormone therapy had a significantly lower urine albumin-to-creatinine ratio and decreased risk of microalbuminuria, compared with those who did not.
Major finding: After adjusting for renal and cardiovascular risk factors, hormone therapy was significantly associated with a lower urine albumin-to-creatinine ratio and a decreased risk of microalbuminuria (OR, 0.61).
Data source: An analysis of 2,217 women enrolled in the Family Blood Pressure Program, a multinetwork effort to study the genetics of hypertension.
Disclosures: The researchers reported having no financial disclosures.
Self-reported poor functional status predicts perioperative morbidity
SAN DIEGO – Among patients with pulmonary hypertension presenting for elective surgery, self-reported poor functional status is associated with multiple comorbidities and is independently predictive of longer hospital length of stay, results from an ongoing single-center study suggest.
“Patients with pulmonary hypertension (PHTN) presenting for elective surgery are at significantly higher risk for adverse perioperative outcomes, including increased hospital length of stay, right ventricular failure, cardiac arrhythmia, persistent postoperative hypoxemia, coronary ischemia and death,” researchers led by Dr. Aalap C. Shah wrote in an abstract presented at the at the annual meeting of the American Society of Anesthesiologists. “The diagnosis of PHTN is based on costly echocardiographic examination and right heart catheterization and should be reserved for high-risk patients. No studies have assessed the role of self-reported functional classification on PHTN severity stratification, and few studies have achieved a sufficiently large patient sample size.”
In an effort to evaluate the predictive value of self-reported exercise tolerance on echocardiogram findings, outcomes, and length of stay (LOS) after noncardiac, nonobstetric surgery, the researchers queried the University of Washington database for all PHTN seen in preoperative anesthesia clinic for noncardiac, nonobstetric procedures from April 2007 through September 2013. Inclusion criteria required an echocardiogram less than 1 year prior to the procedure and available patient-reported functional status, which was defined as less than four metabolic equivalents (METS) in exercise testing or four METS or greater. Dr. Shah, formerly a resident in the University of Washington’s department of anesthesiology and pain medicine, and his associates used univariate analyses to compare functional status with echocardiographic findings, complication rates, and length of stay (LOS). At the meeting he presented results from 294 patients evaluated to date: 143 with normal functional status and 151 with poor functional status. Their mean age was 62 years, and 51% of patients were female.
Compared with their counterparts with normal functional status, patients with poor functional status trended toward a higher complication rate at hospital discharge (14.6% vs. 7%, respectively; P = .041) and had a higher cumulative rate of complications (33 vs. 15; P = .035). However, no association between functional status and complications was observed 30 days postoperatively.
Patients with poor functional status had a significantly longer average LOS, compared with patients with normal functional status (7.21 vs. 4.73 days; P = .047). Open surgical approach was also an independent predictor of increased LOS (odds ratio 2.39; P = .005). No significant independent predictors of complications were observed at discharge or 30 days postoperatively.
“Going forward, the goal is to use these data to create a risk stratification algorithm to figure out: Does a patient with good functional status and pulmonary hypertension undergoing toe surgery, for example, really need an echocardiogram before getting surgery?” said Dr. Shah said, who is now an anesthesiology fellow at Boston Children’s Hospital. “Hopefully we can show that using these risk stratification algorithms can decrease the costs and decrease the time to actually getting surgery.”
The researchers reported having no financial disclosures.
SAN DIEGO – Among patients with pulmonary hypertension presenting for elective surgery, self-reported poor functional status is associated with multiple comorbidities and is independently predictive of longer hospital length of stay, results from an ongoing single-center study suggest.
“Patients with pulmonary hypertension (PHTN) presenting for elective surgery are at significantly higher risk for adverse perioperative outcomes, including increased hospital length of stay, right ventricular failure, cardiac arrhythmia, persistent postoperative hypoxemia, coronary ischemia and death,” researchers led by Dr. Aalap C. Shah wrote in an abstract presented at the at the annual meeting of the American Society of Anesthesiologists. “The diagnosis of PHTN is based on costly echocardiographic examination and right heart catheterization and should be reserved for high-risk patients. No studies have assessed the role of self-reported functional classification on PHTN severity stratification, and few studies have achieved a sufficiently large patient sample size.”
In an effort to evaluate the predictive value of self-reported exercise tolerance on echocardiogram findings, outcomes, and length of stay (LOS) after noncardiac, nonobstetric surgery, the researchers queried the University of Washington database for all PHTN seen in preoperative anesthesia clinic for noncardiac, nonobstetric procedures from April 2007 through September 2013. Inclusion criteria required an echocardiogram less than 1 year prior to the procedure and available patient-reported functional status, which was defined as less than four metabolic equivalents (METS) in exercise testing or four METS or greater. Dr. Shah, formerly a resident in the University of Washington’s department of anesthesiology and pain medicine, and his associates used univariate analyses to compare functional status with echocardiographic findings, complication rates, and length of stay (LOS). At the meeting he presented results from 294 patients evaluated to date: 143 with normal functional status and 151 with poor functional status. Their mean age was 62 years, and 51% of patients were female.
Compared with their counterparts with normal functional status, patients with poor functional status trended toward a higher complication rate at hospital discharge (14.6% vs. 7%, respectively; P = .041) and had a higher cumulative rate of complications (33 vs. 15; P = .035). However, no association between functional status and complications was observed 30 days postoperatively.
Patients with poor functional status had a significantly longer average LOS, compared with patients with normal functional status (7.21 vs. 4.73 days; P = .047). Open surgical approach was also an independent predictor of increased LOS (odds ratio 2.39; P = .005). No significant independent predictors of complications were observed at discharge or 30 days postoperatively.
“Going forward, the goal is to use these data to create a risk stratification algorithm to figure out: Does a patient with good functional status and pulmonary hypertension undergoing toe surgery, for example, really need an echocardiogram before getting surgery?” said Dr. Shah said, who is now an anesthesiology fellow at Boston Children’s Hospital. “Hopefully we can show that using these risk stratification algorithms can decrease the costs and decrease the time to actually getting surgery.”
The researchers reported having no financial disclosures.
SAN DIEGO – Among patients with pulmonary hypertension presenting for elective surgery, self-reported poor functional status is associated with multiple comorbidities and is independently predictive of longer hospital length of stay, results from an ongoing single-center study suggest.
“Patients with pulmonary hypertension (PHTN) presenting for elective surgery are at significantly higher risk for adverse perioperative outcomes, including increased hospital length of stay, right ventricular failure, cardiac arrhythmia, persistent postoperative hypoxemia, coronary ischemia and death,” researchers led by Dr. Aalap C. Shah wrote in an abstract presented at the at the annual meeting of the American Society of Anesthesiologists. “The diagnosis of PHTN is based on costly echocardiographic examination and right heart catheterization and should be reserved for high-risk patients. No studies have assessed the role of self-reported functional classification on PHTN severity stratification, and few studies have achieved a sufficiently large patient sample size.”
In an effort to evaluate the predictive value of self-reported exercise tolerance on echocardiogram findings, outcomes, and length of stay (LOS) after noncardiac, nonobstetric surgery, the researchers queried the University of Washington database for all PHTN seen in preoperative anesthesia clinic for noncardiac, nonobstetric procedures from April 2007 through September 2013. Inclusion criteria required an echocardiogram less than 1 year prior to the procedure and available patient-reported functional status, which was defined as less than four metabolic equivalents (METS) in exercise testing or four METS or greater. Dr. Shah, formerly a resident in the University of Washington’s department of anesthesiology and pain medicine, and his associates used univariate analyses to compare functional status with echocardiographic findings, complication rates, and length of stay (LOS). At the meeting he presented results from 294 patients evaluated to date: 143 with normal functional status and 151 with poor functional status. Their mean age was 62 years, and 51% of patients were female.
Compared with their counterparts with normal functional status, patients with poor functional status trended toward a higher complication rate at hospital discharge (14.6% vs. 7%, respectively; P = .041) and had a higher cumulative rate of complications (33 vs. 15; P = .035). However, no association between functional status and complications was observed 30 days postoperatively.
Patients with poor functional status had a significantly longer average LOS, compared with patients with normal functional status (7.21 vs. 4.73 days; P = .047). Open surgical approach was also an independent predictor of increased LOS (odds ratio 2.39; P = .005). No significant independent predictors of complications were observed at discharge or 30 days postoperatively.
“Going forward, the goal is to use these data to create a risk stratification algorithm to figure out: Does a patient with good functional status and pulmonary hypertension undergoing toe surgery, for example, really need an echocardiogram before getting surgery?” said Dr. Shah said, who is now an anesthesiology fellow at Boston Children’s Hospital. “Hopefully we can show that using these risk stratification algorithms can decrease the costs and decrease the time to actually getting surgery.”
The researchers reported having no financial disclosures.
AT THE ASA ANNUAL MEETING
Key clinical point:Poor self-reported exercise tolerance by patients with pulmonary hypertension is associated with multiple comorbidities and increased hospital length of stay.
Major finding: Compared with their counterparts with normal functional status, patients with poor functional status trended toward a higher complication rate at hospital discharge (14.6% vs. 7%, respectively; P = .041) and had a higher cumulative rate of complications (33 vs. 15; P = .035).
Data source: A study 294 PHTN patients seen in preoperative anesthesia clinic at the University of Washington for non-cardiac, nonobstetric procedures from April 2007 through September 2013.
Disclosures: The researchers reported having no financial disclosures.
PROMIS physical function domain outperforms in cervical spine patients
SAN DIEGO – The Neck Disability Index–10 did not perform as well as the Neck Disability Index–5 in assessing patient-reported outcomes in cervical spine patients – and neither was as good as the PROMIS physical function domain delivered by computerized adaptive testing.
Those are the key findings from an analysis of data from more than 500 cervical spine patients treated at University of Utah Health Care in Salt Lake City.
“Previous studies by us and others have shown problems with the NDI [Neck Disability Index] as it is commonly administered” in 10 questions, lead study author Dr. Darrel S. Brodke said in an interview in advance of the annual meeting of the Cervical Spine Research Society. “It has a very poor floor effect, meaning that it does not differentiate between minimally disabled patients, and the scores cannot be appropriately handled with the kinds of statistics that we normally use – though because few of us know this, we still use it as a standard parametric measure.”
In what he said is the first study of its kind, Dr. Brodke, professor of orthopedics at the University of Utah, and his associates set out to compare the psychometric performance of the National Institutes of Health–funded PROMIS (Patient Reported Outcomes Measurement Information System) physical function (PF) domain, administered by computerized adaptive testing, with the standard NDI-10, the NDI-5, and the 36-Item Short Form physical function domain (SF-36 PFD).
In all, 566 patients completed the NDI and PROMIS PF computerized adaptive testing assessments, while 490 also completed the SF-36 PFD.
On average, the NDI-10 took the longest to complete (10 questions in a mean of 183 seconds), followed by the SF-36 PFD (5 questions in a mean of 123 seconds), the NDI-5 (5 questions in a mean of 99 seconds), and the PROMIS PF computerized adaptive testing (between 4 and 12 questions in a mean of 62 seconds).
The psychometric properties of the PROMIS PF computerized adaptive testing were superior to the other outcome measurement tools studied, Dr. Brodke reported. Specifically, the ceiling and floor effects were “excellent” for the PROMIS PF computerized adaptive testing (1.94% and 4.06%, respectively), while the ceiling effects were “fine” for the NDI-10 (4.77%), NDI-5 (7.60%), and SF-36 PFD (11.84%), he said.
However, the floor effects of these three instruments were poor (45.58%, 48.59% and 21.55%, respectively). “The NDI-10 also has the additional challenge of extremely poor raw score to measure correlation,” the researchers noted in their abstract.
“The legacy scale scores significantly predicted the PROMIS PF CAT scores (P less than .0001), with fair correlation for the PF CAT and NDI-10 (0.53) and good correlation of PF CAT and SF-36 PFD (0.62), allowing use of conversion equations to predict scores, which were generated,” the investigators explained.
PROMIS PF computerized adaptive testing “does much better than the NDI or the SF-36 physical function domain at characterizing patients’ physical function, with much better coverage,” Dr. Brodke said. “Not only this, but it is also much faster to fill out, so less burdensome to the patient and the clinic.”
One limitation of the study is that the researchers did not measure the responsiveness aspect of PROMIS performance. “We did not have enough pre- and posttreatment scores to do this measurement yet,” Dr. Brodke said. “The other thing is that minimum clinically important difference [MCID] is not yet worked out for PROMIS in this patient population, though we can infer an MCID as one-half of a standard deviation. More to come in future studies.”
Dr. Brodke reported having no financial disclosures.
SAN DIEGO – The Neck Disability Index–10 did not perform as well as the Neck Disability Index–5 in assessing patient-reported outcomes in cervical spine patients – and neither was as good as the PROMIS physical function domain delivered by computerized adaptive testing.
Those are the key findings from an analysis of data from more than 500 cervical spine patients treated at University of Utah Health Care in Salt Lake City.
“Previous studies by us and others have shown problems with the NDI [Neck Disability Index] as it is commonly administered” in 10 questions, lead study author Dr. Darrel S. Brodke said in an interview in advance of the annual meeting of the Cervical Spine Research Society. “It has a very poor floor effect, meaning that it does not differentiate between minimally disabled patients, and the scores cannot be appropriately handled with the kinds of statistics that we normally use – though because few of us know this, we still use it as a standard parametric measure.”
In what he said is the first study of its kind, Dr. Brodke, professor of orthopedics at the University of Utah, and his associates set out to compare the psychometric performance of the National Institutes of Health–funded PROMIS (Patient Reported Outcomes Measurement Information System) physical function (PF) domain, administered by computerized adaptive testing, with the standard NDI-10, the NDI-5, and the 36-Item Short Form physical function domain (SF-36 PFD).
In all, 566 patients completed the NDI and PROMIS PF computerized adaptive testing assessments, while 490 also completed the SF-36 PFD.
On average, the NDI-10 took the longest to complete (10 questions in a mean of 183 seconds), followed by the SF-36 PFD (5 questions in a mean of 123 seconds), the NDI-5 (5 questions in a mean of 99 seconds), and the PROMIS PF computerized adaptive testing (between 4 and 12 questions in a mean of 62 seconds).
The psychometric properties of the PROMIS PF computerized adaptive testing were superior to the other outcome measurement tools studied, Dr. Brodke reported. Specifically, the ceiling and floor effects were “excellent” for the PROMIS PF computerized adaptive testing (1.94% and 4.06%, respectively), while the ceiling effects were “fine” for the NDI-10 (4.77%), NDI-5 (7.60%), and SF-36 PFD (11.84%), he said.
However, the floor effects of these three instruments were poor (45.58%, 48.59% and 21.55%, respectively). “The NDI-10 also has the additional challenge of extremely poor raw score to measure correlation,” the researchers noted in their abstract.
“The legacy scale scores significantly predicted the PROMIS PF CAT scores (P less than .0001), with fair correlation for the PF CAT and NDI-10 (0.53) and good correlation of PF CAT and SF-36 PFD (0.62), allowing use of conversion equations to predict scores, which were generated,” the investigators explained.
PROMIS PF computerized adaptive testing “does much better than the NDI or the SF-36 physical function domain at characterizing patients’ physical function, with much better coverage,” Dr. Brodke said. “Not only this, but it is also much faster to fill out, so less burdensome to the patient and the clinic.”
One limitation of the study is that the researchers did not measure the responsiveness aspect of PROMIS performance. “We did not have enough pre- and posttreatment scores to do this measurement yet,” Dr. Brodke said. “The other thing is that minimum clinically important difference [MCID] is not yet worked out for PROMIS in this patient population, though we can infer an MCID as one-half of a standard deviation. More to come in future studies.”
Dr. Brodke reported having no financial disclosures.
SAN DIEGO – The Neck Disability Index–10 did not perform as well as the Neck Disability Index–5 in assessing patient-reported outcomes in cervical spine patients – and neither was as good as the PROMIS physical function domain delivered by computerized adaptive testing.
Those are the key findings from an analysis of data from more than 500 cervical spine patients treated at University of Utah Health Care in Salt Lake City.
“Previous studies by us and others have shown problems with the NDI [Neck Disability Index] as it is commonly administered” in 10 questions, lead study author Dr. Darrel S. Brodke said in an interview in advance of the annual meeting of the Cervical Spine Research Society. “It has a very poor floor effect, meaning that it does not differentiate between minimally disabled patients, and the scores cannot be appropriately handled with the kinds of statistics that we normally use – though because few of us know this, we still use it as a standard parametric measure.”
In what he said is the first study of its kind, Dr. Brodke, professor of orthopedics at the University of Utah, and his associates set out to compare the psychometric performance of the National Institutes of Health–funded PROMIS (Patient Reported Outcomes Measurement Information System) physical function (PF) domain, administered by computerized adaptive testing, with the standard NDI-10, the NDI-5, and the 36-Item Short Form physical function domain (SF-36 PFD).
In all, 566 patients completed the NDI and PROMIS PF computerized adaptive testing assessments, while 490 also completed the SF-36 PFD.
On average, the NDI-10 took the longest to complete (10 questions in a mean of 183 seconds), followed by the SF-36 PFD (5 questions in a mean of 123 seconds), the NDI-5 (5 questions in a mean of 99 seconds), and the PROMIS PF computerized adaptive testing (between 4 and 12 questions in a mean of 62 seconds).
The psychometric properties of the PROMIS PF computerized adaptive testing were superior to the other outcome measurement tools studied, Dr. Brodke reported. Specifically, the ceiling and floor effects were “excellent” for the PROMIS PF computerized adaptive testing (1.94% and 4.06%, respectively), while the ceiling effects were “fine” for the NDI-10 (4.77%), NDI-5 (7.60%), and SF-36 PFD (11.84%), he said.
However, the floor effects of these three instruments were poor (45.58%, 48.59% and 21.55%, respectively). “The NDI-10 also has the additional challenge of extremely poor raw score to measure correlation,” the researchers noted in their abstract.
“The legacy scale scores significantly predicted the PROMIS PF CAT scores (P less than .0001), with fair correlation for the PF CAT and NDI-10 (0.53) and good correlation of PF CAT and SF-36 PFD (0.62), allowing use of conversion equations to predict scores, which were generated,” the investigators explained.
PROMIS PF computerized adaptive testing “does much better than the NDI or the SF-36 physical function domain at characterizing patients’ physical function, with much better coverage,” Dr. Brodke said. “Not only this, but it is also much faster to fill out, so less burdensome to the patient and the clinic.”
One limitation of the study is that the researchers did not measure the responsiveness aspect of PROMIS performance. “We did not have enough pre- and posttreatment scores to do this measurement yet,” Dr. Brodke said. “The other thing is that minimum clinically important difference [MCID] is not yet worked out for PROMIS in this patient population, though we can infer an MCID as one-half of a standard deviation. More to come in future studies.”
Dr. Brodke reported having no financial disclosures.
AT CSRS 2015
Key clinical point: In the elective cervical spine surgery population, the PROMIS physical function domain as delivered by computerized adaptive testing outperforms other commonly used tools to measure patient-reported outcomes.
Major finding: The ceiling and floor effects were “excellent” for the PROMIS PF (1.94% and 4.06%, respectively), while the ceiling effects were “fine” for the Neck Disability Index–10 (4.77%), the Neck Disability Index–5 (7.60%), and the 36-Item Short Form physical function domain (11.84%). However, the floor effects of these three instruments were poor (45.58%, 48.59%, and 21.55%, respectively).
Data source: A study of the psychometric performance of the PROMIS physical function domain, administered by computerized adaptive testing, comparing the standard NDI-10, NDI-5, and SF-36 physical function domain.
Disclosures: Dr. Brodke reported having no financial disclosures.
ASA: Pediatric clinicians over-dispensing opioids, study finds
SAN DIEGO – Pediatric clinicians are dispensing more medicine than needed to treat pain and may be contributing to the epidemic of nonmedical use of prescription opioids, results from a prospective cohort study suggest.
“On the one hand, we have an ethical and more responsibility to treat pain,” Dr. Myron Yaster said in an interview at the annual meeting of the American Society of Anesthesiologists. “I think we’re doing a pretty good job of that. But there’s also a societal issue in what happens to medicines that are left over. That leftover medicine is the most important element in drug addiction. What this study showed is that in the pediatric population, about 60% of what is prescribed is left over.”
As part of a larger ongoing project, Dr. Yaster, professor of pediatric anesthesiology, critical care medicine, and pain management at Johns Hopkins University Hospital, Baltimore, Md., and his associates recruited 433 English-speaking inpatients who were given opioids on discharge from the university’s pediatric hospital. All prescriptions were analyzed by the investigators following discharge for drug, formulation, and amount dispensed. Parents of the patients were interviewed within 2 days of discharge and again up to 2 weeks after discharge to determine if the prescription was filled, to determine pain control on a 4-point Likert scale, how long opioids were used, the amount of medication left at completion of therapy, if patients were given instructions about how to dispose of leftover drug, and if the remaining medications were discarded.
Of the 433 parents, 292 (67%) completed both sets of interviews. The average age of patients was 11 years and their average weight was 44 kg. The majority of patients (89%) were prescribed oxycodone, a liquid formulation 44% of the time. A minority (5%) did not fill their prescriptions, 25% misidentified or did not know the name of their prescription opioid, and patients took opioids for an average of 5 days. “We need to know more about what the prescribers are thinking when they prescribe,” Dr. Yaster said. “Do they actually believe that [patients are] going to take the medicine for 10 days?”
Nearly half of the time (47%), parents rated pain control as “excellent,” followed by “good” (34%), “fair” (10%), or poor (0%). The remaining 9% gave no response. At 2 weeks, an average of 36 opioid tablets and an average of 67 mL of opioid liquid medication remained unused. Overall, patients used only 42% of their prescribed amount.
The researchers also found that 82% of parents were not provided instructions as to what to do with leftover medicine, and only 6% actually did dispose of it. “That means that all that leftover medicine is in people’s medicine cabinets,” Dr. Yaster said. “The study also found that almost half of patients had a teenage sibling. That’s the target population of drug abuse.”
Dr. Yaster reported having no financial disclosures. One of the study authors was Aaron Hsu, a medical student at Johns Hopkins.
SAN DIEGO – Pediatric clinicians are dispensing more medicine than needed to treat pain and may be contributing to the epidemic of nonmedical use of prescription opioids, results from a prospective cohort study suggest.
“On the one hand, we have an ethical and more responsibility to treat pain,” Dr. Myron Yaster said in an interview at the annual meeting of the American Society of Anesthesiologists. “I think we’re doing a pretty good job of that. But there’s also a societal issue in what happens to medicines that are left over. That leftover medicine is the most important element in drug addiction. What this study showed is that in the pediatric population, about 60% of what is prescribed is left over.”
As part of a larger ongoing project, Dr. Yaster, professor of pediatric anesthesiology, critical care medicine, and pain management at Johns Hopkins University Hospital, Baltimore, Md., and his associates recruited 433 English-speaking inpatients who were given opioids on discharge from the university’s pediatric hospital. All prescriptions were analyzed by the investigators following discharge for drug, formulation, and amount dispensed. Parents of the patients were interviewed within 2 days of discharge and again up to 2 weeks after discharge to determine if the prescription was filled, to determine pain control on a 4-point Likert scale, how long opioids were used, the amount of medication left at completion of therapy, if patients were given instructions about how to dispose of leftover drug, and if the remaining medications were discarded.
Of the 433 parents, 292 (67%) completed both sets of interviews. The average age of patients was 11 years and their average weight was 44 kg. The majority of patients (89%) were prescribed oxycodone, a liquid formulation 44% of the time. A minority (5%) did not fill their prescriptions, 25% misidentified or did not know the name of their prescription opioid, and patients took opioids for an average of 5 days. “We need to know more about what the prescribers are thinking when they prescribe,” Dr. Yaster said. “Do they actually believe that [patients are] going to take the medicine for 10 days?”
Nearly half of the time (47%), parents rated pain control as “excellent,” followed by “good” (34%), “fair” (10%), or poor (0%). The remaining 9% gave no response. At 2 weeks, an average of 36 opioid tablets and an average of 67 mL of opioid liquid medication remained unused. Overall, patients used only 42% of their prescribed amount.
The researchers also found that 82% of parents were not provided instructions as to what to do with leftover medicine, and only 6% actually did dispose of it. “That means that all that leftover medicine is in people’s medicine cabinets,” Dr. Yaster said. “The study also found that almost half of patients had a teenage sibling. That’s the target population of drug abuse.”
Dr. Yaster reported having no financial disclosures. One of the study authors was Aaron Hsu, a medical student at Johns Hopkins.
SAN DIEGO – Pediatric clinicians are dispensing more medicine than needed to treat pain and may be contributing to the epidemic of nonmedical use of prescription opioids, results from a prospective cohort study suggest.
“On the one hand, we have an ethical and more responsibility to treat pain,” Dr. Myron Yaster said in an interview at the annual meeting of the American Society of Anesthesiologists. “I think we’re doing a pretty good job of that. But there’s also a societal issue in what happens to medicines that are left over. That leftover medicine is the most important element in drug addiction. What this study showed is that in the pediatric population, about 60% of what is prescribed is left over.”
As part of a larger ongoing project, Dr. Yaster, professor of pediatric anesthesiology, critical care medicine, and pain management at Johns Hopkins University Hospital, Baltimore, Md., and his associates recruited 433 English-speaking inpatients who were given opioids on discharge from the university’s pediatric hospital. All prescriptions were analyzed by the investigators following discharge for drug, formulation, and amount dispensed. Parents of the patients were interviewed within 2 days of discharge and again up to 2 weeks after discharge to determine if the prescription was filled, to determine pain control on a 4-point Likert scale, how long opioids were used, the amount of medication left at completion of therapy, if patients were given instructions about how to dispose of leftover drug, and if the remaining medications were discarded.
Of the 433 parents, 292 (67%) completed both sets of interviews. The average age of patients was 11 years and their average weight was 44 kg. The majority of patients (89%) were prescribed oxycodone, a liquid formulation 44% of the time. A minority (5%) did not fill their prescriptions, 25% misidentified or did not know the name of their prescription opioid, and patients took opioids for an average of 5 days. “We need to know more about what the prescribers are thinking when they prescribe,” Dr. Yaster said. “Do they actually believe that [patients are] going to take the medicine for 10 days?”
Nearly half of the time (47%), parents rated pain control as “excellent,” followed by “good” (34%), “fair” (10%), or poor (0%). The remaining 9% gave no response. At 2 weeks, an average of 36 opioid tablets and an average of 67 mL of opioid liquid medication remained unused. Overall, patients used only 42% of their prescribed amount.
The researchers also found that 82% of parents were not provided instructions as to what to do with leftover medicine, and only 6% actually did dispose of it. “That means that all that leftover medicine is in people’s medicine cabinets,” Dr. Yaster said. “The study also found that almost half of patients had a teenage sibling. That’s the target population of drug abuse.”
Dr. Yaster reported having no financial disclosures. One of the study authors was Aaron Hsu, a medical student at Johns Hopkins.
AT THE ASA ANNUAL MEETING
Key clinical point: Clinicians dispense more opioids than needed to treat pediatric pain.
Major finding: The majority of patients (89%) were prescribed oxycodone, and overall they used only 42% of the opioids they were prescribed.
Data source: A prospective study based on responses from 292 parents of children who were discharged from a university pediatric hospital with an opioid prescription.
Disclosures: Dr. Yaster reported having no financial disclosures.
Blood Pressure Above 140/80 Worsens Proteinuric Diabetic Kidney Disease
SAN DIEGO – Among patients with proteinuric diabetic kidney disease, a mean systolic blood pressure greater than 140 mm Hg and a mean diastolic blood pressure greater than 80 mm Hg were associated with worse renal outcomes, a large national analysis showed.
“Proteinuric diabetic kidney disease frequently progresses to end-stage renal disease,” lead study author Dr. David J. Leehey said at a meeting sponsored by the American Society of Nephrology. “Control of blood pressure delays progression, but the optimal blood pressure to improve outcomes remains unclear.”
In a recent report from the Eighth Joint National Committee, panel members recommended a blood pressure of less than 140/90 mm Hg both for patients with diabetes and patients with chronic kidney disease (JAMA. 2014 Feb 5;311[5]:507-20).
“There are few data with regard to target blood pressure in proteinuric diabetic kidney disease, however, leaving physicians uncertain about how aggressively to lower blood pressure in such patients,” said Dr. Leehey, a nephrologist at the Edward Hines Jr. Veterans Affairs Hospital in Hines, Ill.
In an effort to assess the relationship between blood pressure and renal outcomes in proteinuric diabetic kidney disease, the researchers evaluated blood pressure data from all 1,448 patients who were randomized to the Veterans Affairs Nephropathy in Diabetes (VA NEPHRON-D) trial, which evaluated the combination of losartan with lisinopril, compared with losartan alone (N Engl J Med. 2013 Nov 14;369[20]:1892-1903). Randomization occurred between July 2008 and September 2012, but the trial was halted in October of 2012 due to safety reasons (acute kidney injury and hyperkalemic episodes).
For the current analysis, Dr. Leehey and his associates evaluated the associations of mean on-treatment blood pressure with the primary endpoint (defined as a decline in estimated glomerular filtration rate [eGFR], end-stage renal disease [ESRD], or death), the renal endpoint (defined as a decline in eGFR or cystatin C), the rate of eGFR decline, and mortality.
Trough sitting blood pressure measurements were obtained at every visit during the screening, titration, randomization, and treatment phases of VA NEPHRON-D. Mean blood pressure was defined as the average of all on-treatment blood pressures from the randomization visit to the last blood pressure measurement taken.
Dr. Leehey reported that there were 284 primary endpoints: 132 in the combination group and 152 in the monotherapy group. The mean blood pressure was based on a mean of 7.7 readings per participant.
Both mean systolic and mean diastolic blood pressure were strongly associated with the primary endpoint (P less than .001), univariate analysis revealed. The hazard of developing the primary endpoint increased as the mean systolic blood pressure rose from less than 120 mm Hg to greater than 150 mm Hg (P = .018), multivariate analysis showed.
A significant increase in hazard ratio was seen when mean systolic blood pressure was greater than 140 mm Hg (HR, 1.51). The researchers also observed a significant effect of mean diastolic blood pressure on the hazard of developing the primary endpoint (P = .005), with an increase in hazard ratio when mean diastolic blood pressure was greater than 80 mm Hg (HR, 1.54).
“Associations between BP and both renal endpoint and rate of eGFR decline were similar to those with the primary endpoint,” Dr. Leehey said. “There was a U-shaped relationship between rate of eGFR decline and mean diastolic blood pressure, with the lowest rate of eGFR decline seen when diastolic blood pressure was in the 70-79 mm Hg range. No effect of BP with mortality was observed, possibly because of the limited number of mortality events.”
The study was funded by support from the Veterans Administration. Dr. Leehey reported having no financial disclosures.
SAN DIEGO – Among patients with proteinuric diabetic kidney disease, a mean systolic blood pressure greater than 140 mm Hg and a mean diastolic blood pressure greater than 80 mm Hg were associated with worse renal outcomes, a large national analysis showed.
“Proteinuric diabetic kidney disease frequently progresses to end-stage renal disease,” lead study author Dr. David J. Leehey said at a meeting sponsored by the American Society of Nephrology. “Control of blood pressure delays progression, but the optimal blood pressure to improve outcomes remains unclear.”
In a recent report from the Eighth Joint National Committee, panel members recommended a blood pressure of less than 140/90 mm Hg both for patients with diabetes and patients with chronic kidney disease (JAMA. 2014 Feb 5;311[5]:507-20).
“There are few data with regard to target blood pressure in proteinuric diabetic kidney disease, however, leaving physicians uncertain about how aggressively to lower blood pressure in such patients,” said Dr. Leehey, a nephrologist at the Edward Hines Jr. Veterans Affairs Hospital in Hines, Ill.
In an effort to assess the relationship between blood pressure and renal outcomes in proteinuric diabetic kidney disease, the researchers evaluated blood pressure data from all 1,448 patients who were randomized to the Veterans Affairs Nephropathy in Diabetes (VA NEPHRON-D) trial, which evaluated the combination of losartan with lisinopril, compared with losartan alone (N Engl J Med. 2013 Nov 14;369[20]:1892-1903). Randomization occurred between July 2008 and September 2012, but the trial was halted in October of 2012 due to safety reasons (acute kidney injury and hyperkalemic episodes).
For the current analysis, Dr. Leehey and his associates evaluated the associations of mean on-treatment blood pressure with the primary endpoint (defined as a decline in estimated glomerular filtration rate [eGFR], end-stage renal disease [ESRD], or death), the renal endpoint (defined as a decline in eGFR or cystatin C), the rate of eGFR decline, and mortality.
Trough sitting blood pressure measurements were obtained at every visit during the screening, titration, randomization, and treatment phases of VA NEPHRON-D. Mean blood pressure was defined as the average of all on-treatment blood pressures from the randomization visit to the last blood pressure measurement taken.
Dr. Leehey reported that there were 284 primary endpoints: 132 in the combination group and 152 in the monotherapy group. The mean blood pressure was based on a mean of 7.7 readings per participant.
Both mean systolic and mean diastolic blood pressure were strongly associated with the primary endpoint (P less than .001), univariate analysis revealed. The hazard of developing the primary endpoint increased as the mean systolic blood pressure rose from less than 120 mm Hg to greater than 150 mm Hg (P = .018), multivariate analysis showed.
A significant increase in hazard ratio was seen when mean systolic blood pressure was greater than 140 mm Hg (HR, 1.51). The researchers also observed a significant effect of mean diastolic blood pressure on the hazard of developing the primary endpoint (P = .005), with an increase in hazard ratio when mean diastolic blood pressure was greater than 80 mm Hg (HR, 1.54).
“Associations between BP and both renal endpoint and rate of eGFR decline were similar to those with the primary endpoint,” Dr. Leehey said. “There was a U-shaped relationship between rate of eGFR decline and mean diastolic blood pressure, with the lowest rate of eGFR decline seen when diastolic blood pressure was in the 70-79 mm Hg range. No effect of BP with mortality was observed, possibly because of the limited number of mortality events.”
The study was funded by support from the Veterans Administration. Dr. Leehey reported having no financial disclosures.
SAN DIEGO – Among patients with proteinuric diabetic kidney disease, a mean systolic blood pressure greater than 140 mm Hg and a mean diastolic blood pressure greater than 80 mm Hg were associated with worse renal outcomes, a large national analysis showed.
“Proteinuric diabetic kidney disease frequently progresses to end-stage renal disease,” lead study author Dr. David J. Leehey said at a meeting sponsored by the American Society of Nephrology. “Control of blood pressure delays progression, but the optimal blood pressure to improve outcomes remains unclear.”
In a recent report from the Eighth Joint National Committee, panel members recommended a blood pressure of less than 140/90 mm Hg both for patients with diabetes and patients with chronic kidney disease (JAMA. 2014 Feb 5;311[5]:507-20).
“There are few data with regard to target blood pressure in proteinuric diabetic kidney disease, however, leaving physicians uncertain about how aggressively to lower blood pressure in such patients,” said Dr. Leehey, a nephrologist at the Edward Hines Jr. Veterans Affairs Hospital in Hines, Ill.
In an effort to assess the relationship between blood pressure and renal outcomes in proteinuric diabetic kidney disease, the researchers evaluated blood pressure data from all 1,448 patients who were randomized to the Veterans Affairs Nephropathy in Diabetes (VA NEPHRON-D) trial, which evaluated the combination of losartan with lisinopril, compared with losartan alone (N Engl J Med. 2013 Nov 14;369[20]:1892-1903). Randomization occurred between July 2008 and September 2012, but the trial was halted in October of 2012 due to safety reasons (acute kidney injury and hyperkalemic episodes).
For the current analysis, Dr. Leehey and his associates evaluated the associations of mean on-treatment blood pressure with the primary endpoint (defined as a decline in estimated glomerular filtration rate [eGFR], end-stage renal disease [ESRD], or death), the renal endpoint (defined as a decline in eGFR or cystatin C), the rate of eGFR decline, and mortality.
Trough sitting blood pressure measurements were obtained at every visit during the screening, titration, randomization, and treatment phases of VA NEPHRON-D. Mean blood pressure was defined as the average of all on-treatment blood pressures from the randomization visit to the last blood pressure measurement taken.
Dr. Leehey reported that there were 284 primary endpoints: 132 in the combination group and 152 in the monotherapy group. The mean blood pressure was based on a mean of 7.7 readings per participant.
Both mean systolic and mean diastolic blood pressure were strongly associated with the primary endpoint (P less than .001), univariate analysis revealed. The hazard of developing the primary endpoint increased as the mean systolic blood pressure rose from less than 120 mm Hg to greater than 150 mm Hg (P = .018), multivariate analysis showed.
A significant increase in hazard ratio was seen when mean systolic blood pressure was greater than 140 mm Hg (HR, 1.51). The researchers also observed a significant effect of mean diastolic blood pressure on the hazard of developing the primary endpoint (P = .005), with an increase in hazard ratio when mean diastolic blood pressure was greater than 80 mm Hg (HR, 1.54).
“Associations between BP and both renal endpoint and rate of eGFR decline were similar to those with the primary endpoint,” Dr. Leehey said. “There was a U-shaped relationship between rate of eGFR decline and mean diastolic blood pressure, with the lowest rate of eGFR decline seen when diastolic blood pressure was in the 70-79 mm Hg range. No effect of BP with mortality was observed, possibly because of the limited number of mortality events.”
The study was funded by support from the Veterans Administration. Dr. Leehey reported having no financial disclosures.
AT KIDNEY WEEK 2015
Blood pressure above 140/80 worsens proteinuric diabetic kidney disease
SAN DIEGO – Among patients with proteinuric diabetic kidney disease, a mean systolic blood pressure greater than 140 mm Hg and a mean diastolic blood pressure greater than 80 mm Hg were associated with worse renal outcomes, a large national analysis showed.
“Proteinuric diabetic kidney disease frequently progresses to end-stage renal disease,” lead study author Dr. David J. Leehey said at a meeting sponsored by the American Society of Nephrology. “Control of blood pressure delays progression, but the optimal blood pressure to improve outcomes remains unclear.”
In a recent report from the Eighth Joint National Committee, panel members recommended a blood pressure of less than 140/90 mm Hg both for patients with diabetes and patients with chronic kidney disease (JAMA. 2014 Feb 5;311[5]:507-20).
“There are few data with regard to target blood pressure in proteinuric diabetic kidney disease, however, leaving physicians uncertain about how aggressively to lower blood pressure in such patients,” said Dr. Leehey, a nephrologist at the Edward Hines Jr. Veterans Affairs Hospital in Hines, Ill.
In an effort to assess the relationship between blood pressure and renal outcomes in proteinuric diabetic kidney disease, the researchers evaluated blood pressure data from all 1,448 patients who were randomized to the Veterans Affairs Nephropathy in Diabetes (VA NEPHRON-D) trial, which evaluated the combination of losartan with lisinopril, compared with losartan alone (N Engl J Med. 2013 Nov 14;369[20]:1892-1903). Randomization occurred between July 2008 and September 2012, but the trial was halted in October of 2012 due to safety reasons (acute kidney injury and hyperkalemic episodes).
For the current analysis, Dr. Leehey and his associates evaluated the associations of mean on-treatment blood pressure with the primary endpoint (defined as a decline in estimated glomerular filtration rate [eGFR], end-stage renal disease [ESRD], or death), the renal endpoint (defined as a decline in eGFR or cystatin C), the rate of eGFR decline, and mortality.
Trough sitting blood pressure measurements were obtained at every visit during the screening, titration, randomization, and treatment phases of VA NEPHRON-D. Mean blood pressure was defined as the average of all on-treatment blood pressures from the randomization visit to the last blood pressure measurement taken.
Dr. Leehey reported that there were 284 primary endpoints: 132 in the combination group and 152 in the monotherapy group. The mean blood pressure was based on a mean of 7.7 readings per participant.
Both mean systolic and mean diastolic blood pressure were strongly associated with the primary endpoint (P less than .001), univariate analysis revealed. The hazard of developing the primary endpoint increased as the mean systolic blood pressure rose from less than 120 mm Hg to greater than 150 mm Hg (P = .018), multivariate analysis showed.
A significant increase in hazard ratio was seen when mean systolic blood pressure was greater than 140 mm Hg (HR, 1.51). The researchers also observed a significant effect of mean diastolic blood pressure on the hazard of developing the primary endpoint (P = .005), with an increase in hazard ratio when mean diastolic blood pressure was greater than 80 mm Hg (HR, 1.54).
“Associations between BP and both renal endpoint and rate of eGFR decline were similar to those with the primary endpoint,” Dr. Leehey said. “There was a U-shaped relationship between rate of eGFR decline and mean diastolic blood pressure, with the lowest rate of eGFR decline seen when diastolic blood pressure was in the 70-79 mm Hg range. No effect of BP with mortality was observed, possibly because of the limited number of mortality events.”
The study was funded by support from the Veterans Administration. Dr. Leehey reported having no financial disclosures.
SAN DIEGO – Among patients with proteinuric diabetic kidney disease, a mean systolic blood pressure greater than 140 mm Hg and a mean diastolic blood pressure greater than 80 mm Hg were associated with worse renal outcomes, a large national analysis showed.
“Proteinuric diabetic kidney disease frequently progresses to end-stage renal disease,” lead study author Dr. David J. Leehey said at a meeting sponsored by the American Society of Nephrology. “Control of blood pressure delays progression, but the optimal blood pressure to improve outcomes remains unclear.”
In a recent report from the Eighth Joint National Committee, panel members recommended a blood pressure of less than 140/90 mm Hg both for patients with diabetes and patients with chronic kidney disease (JAMA. 2014 Feb 5;311[5]:507-20).
“There are few data with regard to target blood pressure in proteinuric diabetic kidney disease, however, leaving physicians uncertain about how aggressively to lower blood pressure in such patients,” said Dr. Leehey, a nephrologist at the Edward Hines Jr. Veterans Affairs Hospital in Hines, Ill.
In an effort to assess the relationship between blood pressure and renal outcomes in proteinuric diabetic kidney disease, the researchers evaluated blood pressure data from all 1,448 patients who were randomized to the Veterans Affairs Nephropathy in Diabetes (VA NEPHRON-D) trial, which evaluated the combination of losartan with lisinopril, compared with losartan alone (N Engl J Med. 2013 Nov 14;369[20]:1892-1903). Randomization occurred between July 2008 and September 2012, but the trial was halted in October of 2012 due to safety reasons (acute kidney injury and hyperkalemic episodes).
For the current analysis, Dr. Leehey and his associates evaluated the associations of mean on-treatment blood pressure with the primary endpoint (defined as a decline in estimated glomerular filtration rate [eGFR], end-stage renal disease [ESRD], or death), the renal endpoint (defined as a decline in eGFR or cystatin C), the rate of eGFR decline, and mortality.
Trough sitting blood pressure measurements were obtained at every visit during the screening, titration, randomization, and treatment phases of VA NEPHRON-D. Mean blood pressure was defined as the average of all on-treatment blood pressures from the randomization visit to the last blood pressure measurement taken.
Dr. Leehey reported that there were 284 primary endpoints: 132 in the combination group and 152 in the monotherapy group. The mean blood pressure was based on a mean of 7.7 readings per participant.
Both mean systolic and mean diastolic blood pressure were strongly associated with the primary endpoint (P less than .001), univariate analysis revealed. The hazard of developing the primary endpoint increased as the mean systolic blood pressure rose from less than 120 mm Hg to greater than 150 mm Hg (P = .018), multivariate analysis showed.
A significant increase in hazard ratio was seen when mean systolic blood pressure was greater than 140 mm Hg (HR, 1.51). The researchers also observed a significant effect of mean diastolic blood pressure on the hazard of developing the primary endpoint (P = .005), with an increase in hazard ratio when mean diastolic blood pressure was greater than 80 mm Hg (HR, 1.54).
“Associations between BP and both renal endpoint and rate of eGFR decline were similar to those with the primary endpoint,” Dr. Leehey said. “There was a U-shaped relationship between rate of eGFR decline and mean diastolic blood pressure, with the lowest rate of eGFR decline seen when diastolic blood pressure was in the 70-79 mm Hg range. No effect of BP with mortality was observed, possibly because of the limited number of mortality events.”
The study was funded by support from the Veterans Administration. Dr. Leehey reported having no financial disclosures.
SAN DIEGO – Among patients with proteinuric diabetic kidney disease, a mean systolic blood pressure greater than 140 mm Hg and a mean diastolic blood pressure greater than 80 mm Hg were associated with worse renal outcomes, a large national analysis showed.
“Proteinuric diabetic kidney disease frequently progresses to end-stage renal disease,” lead study author Dr. David J. Leehey said at a meeting sponsored by the American Society of Nephrology. “Control of blood pressure delays progression, but the optimal blood pressure to improve outcomes remains unclear.”
In a recent report from the Eighth Joint National Committee, panel members recommended a blood pressure of less than 140/90 mm Hg both for patients with diabetes and patients with chronic kidney disease (JAMA. 2014 Feb 5;311[5]:507-20).
“There are few data with regard to target blood pressure in proteinuric diabetic kidney disease, however, leaving physicians uncertain about how aggressively to lower blood pressure in such patients,” said Dr. Leehey, a nephrologist at the Edward Hines Jr. Veterans Affairs Hospital in Hines, Ill.
In an effort to assess the relationship between blood pressure and renal outcomes in proteinuric diabetic kidney disease, the researchers evaluated blood pressure data from all 1,448 patients who were randomized to the Veterans Affairs Nephropathy in Diabetes (VA NEPHRON-D) trial, which evaluated the combination of losartan with lisinopril, compared with losartan alone (N Engl J Med. 2013 Nov 14;369[20]:1892-1903). Randomization occurred between July 2008 and September 2012, but the trial was halted in October of 2012 due to safety reasons (acute kidney injury and hyperkalemic episodes).
For the current analysis, Dr. Leehey and his associates evaluated the associations of mean on-treatment blood pressure with the primary endpoint (defined as a decline in estimated glomerular filtration rate [eGFR], end-stage renal disease [ESRD], or death), the renal endpoint (defined as a decline in eGFR or cystatin C), the rate of eGFR decline, and mortality.
Trough sitting blood pressure measurements were obtained at every visit during the screening, titration, randomization, and treatment phases of VA NEPHRON-D. Mean blood pressure was defined as the average of all on-treatment blood pressures from the randomization visit to the last blood pressure measurement taken.
Dr. Leehey reported that there were 284 primary endpoints: 132 in the combination group and 152 in the monotherapy group. The mean blood pressure was based on a mean of 7.7 readings per participant.
Both mean systolic and mean diastolic blood pressure were strongly associated with the primary endpoint (P less than .001), univariate analysis revealed. The hazard of developing the primary endpoint increased as the mean systolic blood pressure rose from less than 120 mm Hg to greater than 150 mm Hg (P = .018), multivariate analysis showed.
A significant increase in hazard ratio was seen when mean systolic blood pressure was greater than 140 mm Hg (HR, 1.51). The researchers also observed a significant effect of mean diastolic blood pressure on the hazard of developing the primary endpoint (P = .005), with an increase in hazard ratio when mean diastolic blood pressure was greater than 80 mm Hg (HR, 1.54).
“Associations between BP and both renal endpoint and rate of eGFR decline were similar to those with the primary endpoint,” Dr. Leehey said. “There was a U-shaped relationship between rate of eGFR decline and mean diastolic blood pressure, with the lowest rate of eGFR decline seen when diastolic blood pressure was in the 70-79 mm Hg range. No effect of BP with mortality was observed, possibly because of the limited number of mortality events.”
The study was funded by support from the Veterans Administration. Dr. Leehey reported having no financial disclosures.
AT KIDNEY WEEK 2015
Key clinical point: In patients with proteinuric diabetic kidney disease, a mean systolic BP greater than 140 mm Hg and a mean diastolic BP greater than 80 mm Hg were linked to worse renal outcomes.
Major finding: A mean systolic blood pressure greater than 140 mm Hg and a mean diastolic blood pressure greater than 80 mm Hg were associated with worse renal outcomes (hazard ratios of 1.51 and 1.54, respectively).
Data source: Blood pressure data from 1,448 patients who were randomized to the VA NEPHRON-D trial, which evaluated the combination of losartan with lisinopril, compared with losartan alone.
Disclosures: The study was funded by support from the Veterans Administration. Dr. Leehey reported having no financial disclosures.
Steroids did not reduce kidney injury in CABG
SAN DIEGO – Among patients undergoing cardiac bypass surgery, perioperative use of corticosteroids did not alter the risk of acute kidney injury, results from a large randomized trial showed.
“Worldwide, over 20 million cardiac surgeries are done each year, but 4 million are complicated by acute kidney injury, and 200,000 are complicated by severe kidney injury treated with dialysis,” Dr. Amit X. Garg said during a press briefing at the annual meeting of the American Society of Nephrology. “So certainly people would benefit from a therapy to prevent acute kidney injury (AKI) and improve the safety of surgery.”
Dr. Garg, a nephrologist at the London Health Sciences Centre in London, Ontario, Canada, noted that cardiopulmonary bypass initiates a systemic inflammatory response syndrome, “which activates complement, inflammatory cytokines, and other inflammatory mediators, which in turn increases endothelial permeability, organ damage, and increased morbidity and mortality, including acute kidney injury.” Researchers are interested in corticosteroids, “because they suppress this inflammatory response. In other settings, such as acute glomerulonephritis, we successfully use corticosteroids to treat acute inflammation in the kidney,” he said.
In a study known as the Steroids in caRdiac Surgery Trial (SIRS), researchers at 79 centers in 18 countries set out to investigate if methylprednisolone alters the risk of acute kidney injury in patients undergoing cardiac surgery with cardiopulmonary bypass. Between June 2007 and December 2013, 7,286 patients were randomized to intravenous methylprednisolone 250 mg at anesthetic induction and 250 mg at initiation of coronary bypass, or placebo.
AKI was defined as a 0.3 mg/dL increase or greater in postoperative serum creatinine concentration from the preoperative concentration within 14 days following surgery, or a 50% increase from the preoperative value within 14 days following surgery. Secondary outcomes included different stages of AKI and receipt of acute dialysis in the 30 days following surgery. Patients, caregivers, and researchers were blinded to the treatment allocation.
Of the 7,286 patients, 3,647 received methylprednisolone and 3,639 received placebo. The mean age of patients was 60 years, 60% were men, 26% were diabetic, and 25% of patients had combined CABG and valve surgery.
The SIRS Investigators reported that the risk of AKI was similar among patients who received methylprednisolone and those who received placebo (40.9% vs. 39.5%, respectively; relative risk 1.03). Results were similar across multiple categorical definitions of AKI, including AKI or death (41.5% vs 40.2%; RR 1.03); AKI stage of 2 or greater (9.9% vs 9.9%; RR 1.01); AKI stage of 3 or greater (4% vs. 4.5%; RR .89), and being on acute dialysis (2.6% vs. 2.4%; RR 1.08).
“There was no benefit of steroids on the risk of AKI in those with or without preoperative chronic kidney disease,” Dr. Garg said. “The result was also not different in the subpopulation of patients with AKI as defined by Kidney Disease Improving Global Outcomes.” Results from SIRS “would suggest that patients undergoing cardiac surgery with cardiopulmonary bypass should not use prophylactic steroids to prevent AKI. When we consider the side effect profile, the most clinically relevant outcomes, and apply the GRADE framework [the Grading of Recommendations Assessment, Development, and Evaluation] to the available evidence, we would recommend that steroids not be used in this way, with a grade 1B recommendation.”
The study was sponsored by the Population Health Research Institute in Hamilton, Ontario and the Canadian Institutes of Health Research. Dr. Garg reported having no relevant financial disclosures for this study.
SAN DIEGO – Among patients undergoing cardiac bypass surgery, perioperative use of corticosteroids did not alter the risk of acute kidney injury, results from a large randomized trial showed.
“Worldwide, over 20 million cardiac surgeries are done each year, but 4 million are complicated by acute kidney injury, and 200,000 are complicated by severe kidney injury treated with dialysis,” Dr. Amit X. Garg said during a press briefing at the annual meeting of the American Society of Nephrology. “So certainly people would benefit from a therapy to prevent acute kidney injury (AKI) and improve the safety of surgery.”
Dr. Garg, a nephrologist at the London Health Sciences Centre in London, Ontario, Canada, noted that cardiopulmonary bypass initiates a systemic inflammatory response syndrome, “which activates complement, inflammatory cytokines, and other inflammatory mediators, which in turn increases endothelial permeability, organ damage, and increased morbidity and mortality, including acute kidney injury.” Researchers are interested in corticosteroids, “because they suppress this inflammatory response. In other settings, such as acute glomerulonephritis, we successfully use corticosteroids to treat acute inflammation in the kidney,” he said.
In a study known as the Steroids in caRdiac Surgery Trial (SIRS), researchers at 79 centers in 18 countries set out to investigate if methylprednisolone alters the risk of acute kidney injury in patients undergoing cardiac surgery with cardiopulmonary bypass. Between June 2007 and December 2013, 7,286 patients were randomized to intravenous methylprednisolone 250 mg at anesthetic induction and 250 mg at initiation of coronary bypass, or placebo.
AKI was defined as a 0.3 mg/dL increase or greater in postoperative serum creatinine concentration from the preoperative concentration within 14 days following surgery, or a 50% increase from the preoperative value within 14 days following surgery. Secondary outcomes included different stages of AKI and receipt of acute dialysis in the 30 days following surgery. Patients, caregivers, and researchers were blinded to the treatment allocation.
Of the 7,286 patients, 3,647 received methylprednisolone and 3,639 received placebo. The mean age of patients was 60 years, 60% were men, 26% were diabetic, and 25% of patients had combined CABG and valve surgery.
The SIRS Investigators reported that the risk of AKI was similar among patients who received methylprednisolone and those who received placebo (40.9% vs. 39.5%, respectively; relative risk 1.03). Results were similar across multiple categorical definitions of AKI, including AKI or death (41.5% vs 40.2%; RR 1.03); AKI stage of 2 or greater (9.9% vs 9.9%; RR 1.01); AKI stage of 3 or greater (4% vs. 4.5%; RR .89), and being on acute dialysis (2.6% vs. 2.4%; RR 1.08).
“There was no benefit of steroids on the risk of AKI in those with or without preoperative chronic kidney disease,” Dr. Garg said. “The result was also not different in the subpopulation of patients with AKI as defined by Kidney Disease Improving Global Outcomes.” Results from SIRS “would suggest that patients undergoing cardiac surgery with cardiopulmonary bypass should not use prophylactic steroids to prevent AKI. When we consider the side effect profile, the most clinically relevant outcomes, and apply the GRADE framework [the Grading of Recommendations Assessment, Development, and Evaluation] to the available evidence, we would recommend that steroids not be used in this way, with a grade 1B recommendation.”
The study was sponsored by the Population Health Research Institute in Hamilton, Ontario and the Canadian Institutes of Health Research. Dr. Garg reported having no relevant financial disclosures for this study.
SAN DIEGO – Among patients undergoing cardiac bypass surgery, perioperative use of corticosteroids did not alter the risk of acute kidney injury, results from a large randomized trial showed.
“Worldwide, over 20 million cardiac surgeries are done each year, but 4 million are complicated by acute kidney injury, and 200,000 are complicated by severe kidney injury treated with dialysis,” Dr. Amit X. Garg said during a press briefing at the annual meeting of the American Society of Nephrology. “So certainly people would benefit from a therapy to prevent acute kidney injury (AKI) and improve the safety of surgery.”
Dr. Garg, a nephrologist at the London Health Sciences Centre in London, Ontario, Canada, noted that cardiopulmonary bypass initiates a systemic inflammatory response syndrome, “which activates complement, inflammatory cytokines, and other inflammatory mediators, which in turn increases endothelial permeability, organ damage, and increased morbidity and mortality, including acute kidney injury.” Researchers are interested in corticosteroids, “because they suppress this inflammatory response. In other settings, such as acute glomerulonephritis, we successfully use corticosteroids to treat acute inflammation in the kidney,” he said.
In a study known as the Steroids in caRdiac Surgery Trial (SIRS), researchers at 79 centers in 18 countries set out to investigate if methylprednisolone alters the risk of acute kidney injury in patients undergoing cardiac surgery with cardiopulmonary bypass. Between June 2007 and December 2013, 7,286 patients were randomized to intravenous methylprednisolone 250 mg at anesthetic induction and 250 mg at initiation of coronary bypass, or placebo.
AKI was defined as a 0.3 mg/dL increase or greater in postoperative serum creatinine concentration from the preoperative concentration within 14 days following surgery, or a 50% increase from the preoperative value within 14 days following surgery. Secondary outcomes included different stages of AKI and receipt of acute dialysis in the 30 days following surgery. Patients, caregivers, and researchers were blinded to the treatment allocation.
Of the 7,286 patients, 3,647 received methylprednisolone and 3,639 received placebo. The mean age of patients was 60 years, 60% were men, 26% were diabetic, and 25% of patients had combined CABG and valve surgery.
The SIRS Investigators reported that the risk of AKI was similar among patients who received methylprednisolone and those who received placebo (40.9% vs. 39.5%, respectively; relative risk 1.03). Results were similar across multiple categorical definitions of AKI, including AKI or death (41.5% vs 40.2%; RR 1.03); AKI stage of 2 or greater (9.9% vs 9.9%; RR 1.01); AKI stage of 3 or greater (4% vs. 4.5%; RR .89), and being on acute dialysis (2.6% vs. 2.4%; RR 1.08).
“There was no benefit of steroids on the risk of AKI in those with or without preoperative chronic kidney disease,” Dr. Garg said. “The result was also not different in the subpopulation of patients with AKI as defined by Kidney Disease Improving Global Outcomes.” Results from SIRS “would suggest that patients undergoing cardiac surgery with cardiopulmonary bypass should not use prophylactic steroids to prevent AKI. When we consider the side effect profile, the most clinically relevant outcomes, and apply the GRADE framework [the Grading of Recommendations Assessment, Development, and Evaluation] to the available evidence, we would recommend that steroids not be used in this way, with a grade 1B recommendation.”
The study was sponsored by the Population Health Research Institute in Hamilton, Ontario and the Canadian Institutes of Health Research. Dr. Garg reported having no relevant financial disclosures for this study.
AT KIDNEY WEEK 2015
Key clinical point: Perioperative use of steroids did not affect the risk of acute kidney injury (AKI) in patients undergoing coronary bypass surgery.
Major finding: The risk of AKI was similar among patients who received methylprednisolone and those who received placebo (40.9% vs. 39.5%, respectively; relative risk 1.03).
Data source: A study of 7,286 patients undergoing cardiopulmonary bypass surgery who were randomized to intravenous methylprednisolone 250 mg at anesthetic induction and 250 mg at initiation of coronary bypass, or placebo.
Disclosures: The study was sponsored by the Population Health Research Institute in Hamilton, Ontario and the Canadian Institutes of Health Research. Dr. Garg reported having no relevant financial disclosures for this study.
Invasive candidiasis hospitalizations down overall
SAN DIEGO – The incidence of hospitalizations associated with invasive candidiasis decreased between 2007 and 2012, but both elderly and black patients remain at greatest risk for the infection, according to an analysis of national data.
“It’s been noted previously that the incidence of neonatal candidiasis seems to be going down, but we wanted to focus on older populations,” Sara Strollo, M.P.H., a trainee in the division of intramural research at the National Institute of Allergy and Infectious Diseases, Rockville., Md., said in an interview at an annual scientific meeting on infectious diseases.
For the study, which is the first of its kind, Ms. Strollo and her associates analyzed data from the State Inpatient Database from the Agency for Healthcare Research and Quality, which represents 97% of all community hospital discharges. They excluded neonatal cases.
The age-adjusted annual incidence of hospitalizations associated with invasive candidiasis ranged from 4.3 to 6.0 per 100,000 persons between 2002 and 2012. The incidence increased from 2002-2005, was stable through 2007, and decreased significantly between 2007 and 2012 -- by 6.7% among men and by 7.4% among women.
The highest incidence of hospitalization for invasive candidiasis occurred among the oldest age groups and among men. For example, compared with persons aged 50-64, the average annual incidence among those over age 80 years old was 2.6-fold higher among women (7.6 vs. 19.7 per 100,000 persons) and 3.9-fold higher among men (7.6 vs. 30 per 100,000 persons).
The researchers also found that among persons older than 50 years of age, black men and women had more than a two-fold higher incidence, compared with white men and women (23.7 vs. 11.7 per 100,000 persons and 22 vs. 10.4 per 100,000 persons, respectively).
During the overall study period, Ms. Strollo and her associates observed a nearly three-fold variation in the average annual incidence of hospital discharges for candidiasis per 100,000 persons, from 2.7 in Oregon to 7.2 in Florida. States with the highest incidence were Florida, Maryland, Missouri, Michigan, California, and Texas, but temporal trends were similar across states and no clear regional patterns among states were observed.
The investigators limited their analysis to 24 states with continuous reporting from 2002 through 2012, which represents 65% of the United States population. The researchers extracted records for discharges where ICD-9 codes for invasive candidiasis were listed in the primary or secondary discharge fields, including disseminated candidiasis (112.5), candidal endocarditis (112.81), and candidal meningitis (112.83). Age, gender, hospitalization year, and state data were extracted, and U.S. Census Bureau data were used as the denominator for state hospitalization incidence and trends. Poisson regression was used to assess significance of trends.
IDWeek marks the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society. The study was supported by a training grant from the National Institute of Child Health and Human Development. The researchers reported having no financial disclosures.
SAN DIEGO – The incidence of hospitalizations associated with invasive candidiasis decreased between 2007 and 2012, but both elderly and black patients remain at greatest risk for the infection, according to an analysis of national data.
“It’s been noted previously that the incidence of neonatal candidiasis seems to be going down, but we wanted to focus on older populations,” Sara Strollo, M.P.H., a trainee in the division of intramural research at the National Institute of Allergy and Infectious Diseases, Rockville., Md., said in an interview at an annual scientific meeting on infectious diseases.
For the study, which is the first of its kind, Ms. Strollo and her associates analyzed data from the State Inpatient Database from the Agency for Healthcare Research and Quality, which represents 97% of all community hospital discharges. They excluded neonatal cases.
The age-adjusted annual incidence of hospitalizations associated with invasive candidiasis ranged from 4.3 to 6.0 per 100,000 persons between 2002 and 2012. The incidence increased from 2002-2005, was stable through 2007, and decreased significantly between 2007 and 2012 -- by 6.7% among men and by 7.4% among women.
The highest incidence of hospitalization for invasive candidiasis occurred among the oldest age groups and among men. For example, compared with persons aged 50-64, the average annual incidence among those over age 80 years old was 2.6-fold higher among women (7.6 vs. 19.7 per 100,000 persons) and 3.9-fold higher among men (7.6 vs. 30 per 100,000 persons).
The researchers also found that among persons older than 50 years of age, black men and women had more than a two-fold higher incidence, compared with white men and women (23.7 vs. 11.7 per 100,000 persons and 22 vs. 10.4 per 100,000 persons, respectively).
During the overall study period, Ms. Strollo and her associates observed a nearly three-fold variation in the average annual incidence of hospital discharges for candidiasis per 100,000 persons, from 2.7 in Oregon to 7.2 in Florida. States with the highest incidence were Florida, Maryland, Missouri, Michigan, California, and Texas, but temporal trends were similar across states and no clear regional patterns among states were observed.
The investigators limited their analysis to 24 states with continuous reporting from 2002 through 2012, which represents 65% of the United States population. The researchers extracted records for discharges where ICD-9 codes for invasive candidiasis were listed in the primary or secondary discharge fields, including disseminated candidiasis (112.5), candidal endocarditis (112.81), and candidal meningitis (112.83). Age, gender, hospitalization year, and state data were extracted, and U.S. Census Bureau data were used as the denominator for state hospitalization incidence and trends. Poisson regression was used to assess significance of trends.
IDWeek marks the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society. The study was supported by a training grant from the National Institute of Child Health and Human Development. The researchers reported having no financial disclosures.
SAN DIEGO – The incidence of hospitalizations associated with invasive candidiasis decreased between 2007 and 2012, but both elderly and black patients remain at greatest risk for the infection, according to an analysis of national data.
“It’s been noted previously that the incidence of neonatal candidiasis seems to be going down, but we wanted to focus on older populations,” Sara Strollo, M.P.H., a trainee in the division of intramural research at the National Institute of Allergy and Infectious Diseases, Rockville., Md., said in an interview at an annual scientific meeting on infectious diseases.
For the study, which is the first of its kind, Ms. Strollo and her associates analyzed data from the State Inpatient Database from the Agency for Healthcare Research and Quality, which represents 97% of all community hospital discharges. They excluded neonatal cases.
The age-adjusted annual incidence of hospitalizations associated with invasive candidiasis ranged from 4.3 to 6.0 per 100,000 persons between 2002 and 2012. The incidence increased from 2002-2005, was stable through 2007, and decreased significantly between 2007 and 2012 -- by 6.7% among men and by 7.4% among women.
The highest incidence of hospitalization for invasive candidiasis occurred among the oldest age groups and among men. For example, compared with persons aged 50-64, the average annual incidence among those over age 80 years old was 2.6-fold higher among women (7.6 vs. 19.7 per 100,000 persons) and 3.9-fold higher among men (7.6 vs. 30 per 100,000 persons).
The researchers also found that among persons older than 50 years of age, black men and women had more than a two-fold higher incidence, compared with white men and women (23.7 vs. 11.7 per 100,000 persons and 22 vs. 10.4 per 100,000 persons, respectively).
During the overall study period, Ms. Strollo and her associates observed a nearly three-fold variation in the average annual incidence of hospital discharges for candidiasis per 100,000 persons, from 2.7 in Oregon to 7.2 in Florida. States with the highest incidence were Florida, Maryland, Missouri, Michigan, California, and Texas, but temporal trends were similar across states and no clear regional patterns among states were observed.
The investigators limited their analysis to 24 states with continuous reporting from 2002 through 2012, which represents 65% of the United States population. The researchers extracted records for discharges where ICD-9 codes for invasive candidiasis were listed in the primary or secondary discharge fields, including disseminated candidiasis (112.5), candidal endocarditis (112.81), and candidal meningitis (112.83). Age, gender, hospitalization year, and state data were extracted, and U.S. Census Bureau data were used as the denominator for state hospitalization incidence and trends. Poisson regression was used to assess significance of trends.
IDWeek marks the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society. The study was supported by a training grant from the National Institute of Child Health and Human Development. The researchers reported having no financial disclosures.
AT IDWEEK 2015
Key clinical point: As of 2007, the incidence of hospital-associated invasive candidiasis appears to be decreasing.
Major finding: Between 2007 and 2012, the age-adjusted annual incidence of hospitalizations associated with invasive candidiasis in the United States decreased by 6.7% among men and by 7.4% among women.
Data source: A long-term analysis of data from the State Inpatient Database from the Agency for Healthcare Research and Quality.
Disclosures: The researchers reported having no financial disclosures.
Human trial of wearable artificial kidney shows promise
SAN DIEGO – Patients undergoing maintenance hemodialysis who wore an artificial kidney for 24 hours achieved electrolyte, solute, and volume homeostasis, results from a small exploratory trial demonstrated.
“Mortality in dialysis patients is unacceptable high and the cost is enormous,” device inventor Dr. Victor Gura said during a press briefing at the annual meeting of the American Society of Nephrology. “They have a significant amount of heart disease, strokes and infections, and yet it’s a demographic issue with more than 500,000 patients in the U.S. with end-stage renal disease.”
In a trial supported through the FDA’s Center for Devices and Radiological Health, the investigators conducted a human trial of a wearable artificial kidney, a miniaturized, wearable hemodialysis machine based on dialysate-regenerating sorbent technology that is being developed by Blood Purification Technologies. The objective was to determine the safety and efficacy of the device in achieving electrolyte, solute, and volume homeostasis over a 24-hour period in seven patients.
Dr. Gura, a nephrologist at Cedars-Sinai Medical Center and the David Geffen School of Medicine at the University of California, Los Angeles, reported that all patients remained hemodynamically stable, and there were no serious adverse events over the study period. Fluid removal was consistent with prescribed ultrafiltration. Mean BUN, creatinine, and phosphorus clearances during the first hour of treatment were 21, 20, and 22 mL/min, respectively. Treatment was stopped in one patient due to clotting after four hours. Treatment was stopped in a second patient due to discoloration of dialysate observed after 10 hours. The trial was halted after the seventh patient was enrolled due to device-related problems, including carbon dioxide bubbles in the dialysis circuit, tubing kinks, and variable blood/dialysate flow.
Six out of seven patients ambulated while receiving treatment, and all were able to eat a normal diet with ad lib ingestion of water, without restriction on salt, phosphate, or potassium-rich foods. In semi-structured interviews, all patients reported that they would switch to the device if it were commercially available.
In an abstract describing the study, the researchers characterized the findings “as proof-of-concept of the wearable artificial kidney as an important novel alternative dialysis technology that has the potential to enhance autonomy and improve health-related quality of life for patients with end-stage renal disease.”
The study was supported by an unrestricted grant from the Wearable Artificial Kidney Foundation and by Blood Purification Technologies Inc. One of the study investigators, Dr. Matthew B. Rivara, is supported by a grant from the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Gura reported having no financial disclosures.
SAN DIEGO – Patients undergoing maintenance hemodialysis who wore an artificial kidney for 24 hours achieved electrolyte, solute, and volume homeostasis, results from a small exploratory trial demonstrated.
“Mortality in dialysis patients is unacceptable high and the cost is enormous,” device inventor Dr. Victor Gura said during a press briefing at the annual meeting of the American Society of Nephrology. “They have a significant amount of heart disease, strokes and infections, and yet it’s a demographic issue with more than 500,000 patients in the U.S. with end-stage renal disease.”
In a trial supported through the FDA’s Center for Devices and Radiological Health, the investigators conducted a human trial of a wearable artificial kidney, a miniaturized, wearable hemodialysis machine based on dialysate-regenerating sorbent technology that is being developed by Blood Purification Technologies. The objective was to determine the safety and efficacy of the device in achieving electrolyte, solute, and volume homeostasis over a 24-hour period in seven patients.
Dr. Gura, a nephrologist at Cedars-Sinai Medical Center and the David Geffen School of Medicine at the University of California, Los Angeles, reported that all patients remained hemodynamically stable, and there were no serious adverse events over the study period. Fluid removal was consistent with prescribed ultrafiltration. Mean BUN, creatinine, and phosphorus clearances during the first hour of treatment were 21, 20, and 22 mL/min, respectively. Treatment was stopped in one patient due to clotting after four hours. Treatment was stopped in a second patient due to discoloration of dialysate observed after 10 hours. The trial was halted after the seventh patient was enrolled due to device-related problems, including carbon dioxide bubbles in the dialysis circuit, tubing kinks, and variable blood/dialysate flow.
Six out of seven patients ambulated while receiving treatment, and all were able to eat a normal diet with ad lib ingestion of water, without restriction on salt, phosphate, or potassium-rich foods. In semi-structured interviews, all patients reported that they would switch to the device if it were commercially available.
In an abstract describing the study, the researchers characterized the findings “as proof-of-concept of the wearable artificial kidney as an important novel alternative dialysis technology that has the potential to enhance autonomy and improve health-related quality of life for patients with end-stage renal disease.”
The study was supported by an unrestricted grant from the Wearable Artificial Kidney Foundation and by Blood Purification Technologies Inc. One of the study investigators, Dr. Matthew B. Rivara, is supported by a grant from the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Gura reported having no financial disclosures.
SAN DIEGO – Patients undergoing maintenance hemodialysis who wore an artificial kidney for 24 hours achieved electrolyte, solute, and volume homeostasis, results from a small exploratory trial demonstrated.
“Mortality in dialysis patients is unacceptable high and the cost is enormous,” device inventor Dr. Victor Gura said during a press briefing at the annual meeting of the American Society of Nephrology. “They have a significant amount of heart disease, strokes and infections, and yet it’s a demographic issue with more than 500,000 patients in the U.S. with end-stage renal disease.”
In a trial supported through the FDA’s Center for Devices and Radiological Health, the investigators conducted a human trial of a wearable artificial kidney, a miniaturized, wearable hemodialysis machine based on dialysate-regenerating sorbent technology that is being developed by Blood Purification Technologies. The objective was to determine the safety and efficacy of the device in achieving electrolyte, solute, and volume homeostasis over a 24-hour period in seven patients.
Dr. Gura, a nephrologist at Cedars-Sinai Medical Center and the David Geffen School of Medicine at the University of California, Los Angeles, reported that all patients remained hemodynamically stable, and there were no serious adverse events over the study period. Fluid removal was consistent with prescribed ultrafiltration. Mean BUN, creatinine, and phosphorus clearances during the first hour of treatment were 21, 20, and 22 mL/min, respectively. Treatment was stopped in one patient due to clotting after four hours. Treatment was stopped in a second patient due to discoloration of dialysate observed after 10 hours. The trial was halted after the seventh patient was enrolled due to device-related problems, including carbon dioxide bubbles in the dialysis circuit, tubing kinks, and variable blood/dialysate flow.
Six out of seven patients ambulated while receiving treatment, and all were able to eat a normal diet with ad lib ingestion of water, without restriction on salt, phosphate, or potassium-rich foods. In semi-structured interviews, all patients reported that they would switch to the device if it were commercially available.
In an abstract describing the study, the researchers characterized the findings “as proof-of-concept of the wearable artificial kidney as an important novel alternative dialysis technology that has the potential to enhance autonomy and improve health-related quality of life for patients with end-stage renal disease.”
The study was supported by an unrestricted grant from the Wearable Artificial Kidney Foundation and by Blood Purification Technologies Inc. One of the study investigators, Dr. Matthew B. Rivara, is supported by a grant from the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Gura reported having no financial disclosures.
AT KIDNEY WEEK 2015
Key clinical point: Treatment with a wearable kidney was well tolerated and resulted in effective homeostasis.
Major finding: All patients remained hemodynamically stable, and there were no serious adverse events over the study period.
Data source: An exploratory study of 7 dialysis patients who wore an artificial kidney for 24 hours.
Disclosures: The study was supported by an unrestricted grant from the Wearable Artificial Kidney Foundation and by Blood Purification Technologies Inc. One of the study investigators, Dr. Matthew B. Rivara, is supported by a grant from the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Gura reported having no financial disclosures.
