Doug Brunk

SAN DIEGO – Empagliflozin used in conjunction with standard of care significantly improved renal outcomes in adults with type 2 diabetes, results from a large randomized trial showed.

“These benefits were consistent among patients with and without chronic kidney disease at baseline,” Dr. Christoph Wanner said at the annual meeting of the American Society of Nephrology.

Previous studies have demonstrated that in patients with type 2 diabetes, empagliflozin, an inhibitor of the sodium glucose cotransporter 2 in the kidney, leads to significant reductions in hemoglobin A_1c, weight loss, and reductions in blood pressure without increases in heart rate. Developed by Boehringer Ingelheim and Eli Lilly, the drug was approved in 2014 for the treatment of type 2 diabetes in adults. At the meeting Dr. Wanner presented new finding results from the EMPA-REG OUTCOME trial, which was published in September 2015. That study found that patients with type 2 diabetes at high risk for cardiovascular events who received empagliflozin, compared with placebo, had a lower rate of the primary composite cardiovascular outcome and death from any cause when the study drug was added to standard care.

For the current analysis, the researchers evaluated renal outcomes in the study participants, which consisted of new-onset or worsening nephropathy, including new onset of macroalbuminuria (defined as a urine albumin to creatinine ratio (UACR) of greater than 300 mg/g); doubling of serum creatinine accompanied by an estimated glomerular filtration rate (eGFR) of 45 mL/min/1.73m² or less; initiation of renal replacement therapy; or death due to renal disease. There was also a composite outcome of doubling of serum creatinine, initiation of renal replacement therapy, or death due to renal disease.

The EMPA-REG OUTCOME trial included 2,333 patients in the placebo group and 4,687 in the empagliflozin group who were followed for a median observation time of 3.1 years. The mean age of the study participants was 63 years and 71% were male. Compared with patients in the placebo group, those in the empagliflozin group demonstrated a 39% reduction in new-onset or worsening of nephropathy (hazard ratio, 0.61; P less than .0001). The reduction “started very early,” said Dr. Wanner, who is professor of medicine and head of nephrology at University Hospital of Wurzburg, Germany. “After 3 months you see the curves [between the placebo and treatment groups] separating.”

The impact on empagliflozin on the composite outcome of doubling of serum creatinine, initiation of renal replacement therapy, or death due to renal disease was even more profound. Compared with patients in the placebo group, those in the empagliflozin demonstrated a 46% reduced risk in the composite outcome (HR, 0.54; P = .0002).

Dr. Wanner went on to present cardiovascular outcomes in patients with chronic kidney disease (CKD). Among those with an eGFR of less than 60 mL/min/1.73m² at baseline, the primary outcome of three-point major adverse cardiac events occurred in 176 of 1,212 patients in the empagliflozin group (15%), compared with 99 of 607 patients in the placebo group (16%; HR, 0.88). Among those with an eGFR of 60 mL/min/1.73m² or greater at baseline, the primary outcome of three-point major adverse cardiac events occurred in 314 of 3,473 patients in the empagliflozin group (9%), compared with 183 of 1,726 (11%) patients in the placebo group (HR, 0.84). At the same time, the outcome of cardiovascular death occurred in 75 of 1,212 patients in the empagliflozin group (6%), compared with 48 of 607 patients in the placebo group (8%; HR, 0.78). Among those with an eGFR of 60 mL/min/1.73m² or greater at baseline, cardiovascular death occurred in 97 of 3,473 patients in the empagliflozin group (3%), compared with 89 of 1,726 patients in the placebo group (5%; HR, 0.53). However, there was no detectable benefit for the study medication in reducing the myocardial infarction or stroke in patients with CKD.

Among those with an eGFR of less than 60 mL/min/1.73m² at baseline, hospitalization for heart failure occurred in 51 of 1,212 patients in the empagliflozin group (4%), compared with 43 of 607 patients in the placebo group (7%; HR, 0.59). Among those with an eGFR of 60 mL/min/1.73m² or greater at baseline, hospitalization for heart failure occurred in 75 of 3,473 patients in the empagliflozin group (2%), compared with 52 of 1,726 patients in the placebo group (3%; HR, 0.70). At the same time, all-cause mortality occurred in 115 of 1,212 patients in the empagliflozin group (9%), compared with 72 of 607 patients in the placebo group (12%; HR, 0.80). Among those with an eGFR of 60 mL/min/1.73m² or greater at baseline, hospitalization for heart failure occurred in 154 of 3,473 patients in the empagliflozin group (4%), compared with 122 of 1,726 patients in the placebo group (7%; HR, 0.62).

The most common adverse events in patients with CKD related to the study drug were urinary tract infections and genital infections, but there were no detectable signals on acute kidney failure, hyperkalemia, or bone fracture.

“Empagliflozin reduces cardiovascular death, all-cause mortality, and hospitalization for heart failure in patients with type 2 diabetes at high cardiovascular risk,” Dr. Wanner concluded. “Safety and tolerability of empagliflozin in patients with CKD at baseline were similar to the overall trial population and consistent with previous clinical trials.”

The study was supported by Boehringer Ingelheim and Eli Lilly. Dr. Wanner disclosed numerous financial ties to industry.

dbrunk@frontlinemedcom.com

SAN DIEGO – Empagliflozin used in conjunction with standard of care significantly improved renal outcomes in adults with type 2 diabetes, results from a large randomized trial showed.

“These benefits were consistent among patients with and without chronic kidney disease at baseline,” Dr. Christoph Wanner said at the annual meeting of the American Society of Nephrology.

Previous studies have demonstrated that in patients with type 2 diabetes, empagliflozin, an inhibitor of the sodium glucose cotransporter 2 in the kidney, leads to significant reductions in hemoglobin A_1c, weight loss, and reductions in blood pressure without increases in heart rate. Developed by Boehringer Ingelheim and Eli Lilly, the drug was approved in 2014 for the treatment of type 2 diabetes in adults. At the meeting Dr. Wanner presented new finding results from the EMPA-REG OUTCOME trial, which was published in September 2015. That study found that patients with type 2 diabetes at high risk for cardiovascular events who received empagliflozin, compared with placebo, had a lower rate of the primary composite cardiovascular outcome and death from any cause when the study drug was added to standard care.

For the current analysis, the researchers evaluated renal outcomes in the study participants, which consisted of new-onset or worsening nephropathy, including new onset of macroalbuminuria (defined as a urine albumin to creatinine ratio (UACR) of greater than 300 mg/g); doubling of serum creatinine accompanied by an estimated glomerular filtration rate (eGFR) of 45 mL/min/1.73m² or less; initiation of renal replacement therapy; or death due to renal disease. There was also a composite outcome of doubling of serum creatinine, initiation of renal replacement therapy, or death due to renal disease.

The EMPA-REG OUTCOME trial included 2,333 patients in the placebo group and 4,687 in the empagliflozin group who were followed for a median observation time of 3.1 years. The mean age of the study participants was 63 years and 71% were male. Compared with patients in the placebo group, those in the empagliflozin group demonstrated a 39% reduction in new-onset or worsening of nephropathy (hazard ratio, 0.61; P less than .0001). The reduction “started very early,” said Dr. Wanner, who is professor of medicine and head of nephrology at University Hospital of Wurzburg, Germany. “After 3 months you see the curves [between the placebo and treatment groups] separating.”

The impact on empagliflozin on the composite outcome of doubling of serum creatinine, initiation of renal replacement therapy, or death due to renal disease was even more profound. Compared with patients in the placebo group, those in the empagliflozin demonstrated a 46% reduced risk in the composite outcome (HR, 0.54; P = .0002).

Dr. Wanner went on to present cardiovascular outcomes in patients with chronic kidney disease (CKD). Among those with an eGFR of less than 60 mL/min/1.73m² at baseline, the primary outcome of three-point major adverse cardiac events occurred in 176 of 1,212 patients in the empagliflozin group (15%), compared with 99 of 607 patients in the placebo group (16%; HR, 0.88). Among those with an eGFR of 60 mL/min/1.73m² or greater at baseline, the primary outcome of three-point major adverse cardiac events occurred in 314 of 3,473 patients in the empagliflozin group (9%), compared with 183 of 1,726 (11%) patients in the placebo group (HR, 0.84). At the same time, the outcome of cardiovascular death occurred in 75 of 1,212 patients in the empagliflozin group (6%), compared with 48 of 607 patients in the placebo group (8%; HR, 0.78). Among those with an eGFR of 60 mL/min/1.73m² or greater at baseline, cardiovascular death occurred in 97 of 3,473 patients in the empagliflozin group (3%), compared with 89 of 1,726 patients in the placebo group (5%; HR, 0.53). However, there was no detectable benefit for the study medication in reducing the myocardial infarction or stroke in patients with CKD.

Among those with an eGFR of less than 60 mL/min/1.73m² at baseline, hospitalization for heart failure occurred in 51 of 1,212 patients in the empagliflozin group (4%), compared with 43 of 607 patients in the placebo group (7%; HR, 0.59). Among those with an eGFR of 60 mL/min/1.73m² or greater at baseline, hospitalization for heart failure occurred in 75 of 3,473 patients in the empagliflozin group (2%), compared with 52 of 1,726 patients in the placebo group (3%; HR, 0.70). At the same time, all-cause mortality occurred in 115 of 1,212 patients in the empagliflozin group (9%), compared with 72 of 607 patients in the placebo group (12%; HR, 0.80). Among those with an eGFR of 60 mL/min/1.73m² or greater at baseline, hospitalization for heart failure occurred in 154 of 3,473 patients in the empagliflozin group (4%), compared with 122 of 1,726 patients in the placebo group (7%; HR, 0.62).

The most common adverse events in patients with CKD related to the study drug were urinary tract infections and genital infections, but there were no detectable signals on acute kidney failure, hyperkalemia, or bone fracture.

“Empagliflozin reduces cardiovascular death, all-cause mortality, and hospitalization for heart failure in patients with type 2 diabetes at high cardiovascular risk,” Dr. Wanner concluded. “Safety and tolerability of empagliflozin in patients with CKD at baseline were similar to the overall trial population and consistent with previous clinical trials.”

The study was supported by Boehringer Ingelheim and Eli Lilly. Dr. Wanner disclosed numerous financial ties to industry.

dbrunk@frontlinemedcom.com

SAN DIEGO – Empagliflozin used in conjunction with standard of care significantly improved renal outcomes in adults with type 2 diabetes, results from a large randomized trial showed.

“These benefits were consistent among patients with and without chronic kidney disease at baseline,” Dr. Christoph Wanner said at the annual meeting of the American Society of Nephrology.

Previous studies have demonstrated that in patients with type 2 diabetes, empagliflozin, an inhibitor of the sodium glucose cotransporter 2 in the kidney, leads to significant reductions in hemoglobin A_1c, weight loss, and reductions in blood pressure without increases in heart rate. Developed by Boehringer Ingelheim and Eli Lilly, the drug was approved in 2014 for the treatment of type 2 diabetes in adults. At the meeting Dr. Wanner presented new finding results from the EMPA-REG OUTCOME trial, which was published in September 2015. That study found that patients with type 2 diabetes at high risk for cardiovascular events who received empagliflozin, compared with placebo, had a lower rate of the primary composite cardiovascular outcome and death from any cause when the study drug was added to standard care.

For the current analysis, the researchers evaluated renal outcomes in the study participants, which consisted of new-onset or worsening nephropathy, including new onset of macroalbuminuria (defined as a urine albumin to creatinine ratio (UACR) of greater than 300 mg/g); doubling of serum creatinine accompanied by an estimated glomerular filtration rate (eGFR) of 45 mL/min/1.73m² or less; initiation of renal replacement therapy; or death due to renal disease. There was also a composite outcome of doubling of serum creatinine, initiation of renal replacement therapy, or death due to renal disease.

The EMPA-REG OUTCOME trial included 2,333 patients in the placebo group and 4,687 in the empagliflozin group who were followed for a median observation time of 3.1 years. The mean age of the study participants was 63 years and 71% were male. Compared with patients in the placebo group, those in the empagliflozin group demonstrated a 39% reduction in new-onset or worsening of nephropathy (hazard ratio, 0.61; P less than .0001). The reduction “started very early,” said Dr. Wanner, who is professor of medicine and head of nephrology at University Hospital of Wurzburg, Germany. “After 3 months you see the curves [between the placebo and treatment groups] separating.”

The impact on empagliflozin on the composite outcome of doubling of serum creatinine, initiation of renal replacement therapy, or death due to renal disease was even more profound. Compared with patients in the placebo group, those in the empagliflozin demonstrated a 46% reduced risk in the composite outcome (HR, 0.54; P = .0002).

Dr. Wanner went on to present cardiovascular outcomes in patients with chronic kidney disease (CKD). Among those with an eGFR of less than 60 mL/min/1.73m² at baseline, the primary outcome of three-point major adverse cardiac events occurred in 176 of 1,212 patients in the empagliflozin group (15%), compared with 99 of 607 patients in the placebo group (16%; HR, 0.88). Among those with an eGFR of 60 mL/min/1.73m² or greater at baseline, the primary outcome of three-point major adverse cardiac events occurred in 314 of 3,473 patients in the empagliflozin group (9%), compared with 183 of 1,726 (11%) patients in the placebo group (HR, 0.84). At the same time, the outcome of cardiovascular death occurred in 75 of 1,212 patients in the empagliflozin group (6%), compared with 48 of 607 patients in the placebo group (8%; HR, 0.78). Among those with an eGFR of 60 mL/min/1.73m² or greater at baseline, cardiovascular death occurred in 97 of 3,473 patients in the empagliflozin group (3%), compared with 89 of 1,726 patients in the placebo group (5%; HR, 0.53). However, there was no detectable benefit for the study medication in reducing the myocardial infarction or stroke in patients with CKD.

Among those with an eGFR of less than 60 mL/min/1.73m² at baseline, hospitalization for heart failure occurred in 51 of 1,212 patients in the empagliflozin group (4%), compared with 43 of 607 patients in the placebo group (7%; HR, 0.59). Among those with an eGFR of 60 mL/min/1.73m² or greater at baseline, hospitalization for heart failure occurred in 75 of 3,473 patients in the empagliflozin group (2%), compared with 52 of 1,726 patients in the placebo group (3%; HR, 0.70). At the same time, all-cause mortality occurred in 115 of 1,212 patients in the empagliflozin group (9%), compared with 72 of 607 patients in the placebo group (12%; HR, 0.80). Among those with an eGFR of 60 mL/min/1.73m² or greater at baseline, hospitalization for heart failure occurred in 154 of 3,473 patients in the empagliflozin group (4%), compared with 122 of 1,726 patients in the placebo group (7%; HR, 0.62).

The most common adverse events in patients with CKD related to the study drug were urinary tract infections and genital infections, but there were no detectable signals on acute kidney failure, hyperkalemia, or bone fracture.

“Empagliflozin reduces cardiovascular death, all-cause mortality, and hospitalization for heart failure in patients with type 2 diabetes at high cardiovascular risk,” Dr. Wanner concluded. “Safety and tolerability of empagliflozin in patients with CKD at baseline were similar to the overall trial population and consistent with previous clinical trials.”

The study was supported by Boehringer Ingelheim and Eli Lilly. Dr. Wanner disclosed numerous financial ties to industry.

dbrunk@frontlinemedcom.com

SAN DIEGO – Nearly one-third of pain-related emergency room visits or hospital readmissions following same-day surgery were attributable to inadequate pain management in the peridischarge period, a large single-center analysis demonstrated.

“Pain management in the perioperative period is largely an anesthesiologist responsibility, but maybe it would be helpful if it was a little bit more multispecialty, if we had more communication,” study author Dr. Martha O. Herbst said in an interview at the annual meeting of the American Society of Anesthesiologists.

“There were some patients who came back for pain because they didn’t even receive prescriptions from their surgeon. Maybe a little better communication between the anesthesiologist and the surgeon on how to optimize specific patients and prevent those readmissions for pain would help,” she said.

Inspired by a similar study published in 2002 (J Clin Anesth. 2002;14[5]:349-53), Dr. Herbst, a fourth-year anesthesiology resident at Beaumont Hospital in Royal Oak, Mich., and her associates retrospectively evaluated the number of readmissions or revisits that occurred among 28,647 patients who underwent same-day surgery in the Beaumont Health system in 2012. A total of 1,559 revisits occurred during the study period. Of these, 621 (39.8%) were revisits related to the surgical procedure and 145 (9.3% overall and 23.3% of readmissions) were due to pain.

The researchers then stratified patients into one of six categories for readmission. These included all-cause pain (16%); surgical-related issues such as wound opening or reinfection (21%); medical issues such as exacerbation of chronic obstructive pulmonary disease (43%); bleeding complications such as hematuria, hemodialysis, and surgical site bleeding (6%); adverse medical reactions (2%); and other (12%).

Of the 145 patients who were readmitted for pain from the same-day surgery, 71% were deemed to have no pre-existing risk for readmission while 29% had at least one risk factor for readmission. These included opioid monotherapy during the procedure (11%), history of chronic pain (9%), no pain medication given during the procedure (4%), inadequate doses of analgesics used (3%), and discharge without a prescription for an analgesic (2%).

“There were people who got tiny doses of pain medications after a huge, painful procedure, so that was surprising,” Dr. Herbst said. “Maybe they weren’t optimally managed at the time of surgery.”

The findings, she concluded, underscore the need for a team-based approach to pain management in the same-day surgery population, with discharge planning focused on patient education, expectation management, multimodal analgesia optimization, and pain risk assessment.

The researchers reported having no financial disclosures.

dbrunk@frontlinemedcom.com

SAN DIEGO – Nearly one-third of pain-related emergency room visits or hospital readmissions following same-day surgery were attributable to inadequate pain management in the peridischarge period, a large single-center analysis demonstrated.

“Pain management in the perioperative period is largely an anesthesiologist responsibility, but maybe it would be helpful if it was a little bit more multispecialty, if we had more communication,” study author Dr. Martha O. Herbst said in an interview at the annual meeting of the American Society of Anesthesiologists.

“There were some patients who came back for pain because they didn’t even receive prescriptions from their surgeon. Maybe a little better communication between the anesthesiologist and the surgeon on how to optimize specific patients and prevent those readmissions for pain would help,” she said.

Inspired by a similar study published in 2002 (J Clin Anesth. 2002;14[5]:349-53), Dr. Herbst, a fourth-year anesthesiology resident at Beaumont Hospital in Royal Oak, Mich., and her associates retrospectively evaluated the number of readmissions or revisits that occurred among 28,647 patients who underwent same-day surgery in the Beaumont Health system in 2012. A total of 1,559 revisits occurred during the study period. Of these, 621 (39.8%) were revisits related to the surgical procedure and 145 (9.3% overall and 23.3% of readmissions) were due to pain.

The researchers then stratified patients into one of six categories for readmission. These included all-cause pain (16%); surgical-related issues such as wound opening or reinfection (21%); medical issues such as exacerbation of chronic obstructive pulmonary disease (43%); bleeding complications such as hematuria, hemodialysis, and surgical site bleeding (6%); adverse medical reactions (2%); and other (12%).

Of the 145 patients who were readmitted for pain from the same-day surgery, 71% were deemed to have no pre-existing risk for readmission while 29% had at least one risk factor for readmission. These included opioid monotherapy during the procedure (11%), history of chronic pain (9%), no pain medication given during the procedure (4%), inadequate doses of analgesics used (3%), and discharge without a prescription for an analgesic (2%).

“There were people who got tiny doses of pain medications after a huge, painful procedure, so that was surprising,” Dr. Herbst said. “Maybe they weren’t optimally managed at the time of surgery.”

The findings, she concluded, underscore the need for a team-based approach to pain management in the same-day surgery population, with discharge planning focused on patient education, expectation management, multimodal analgesia optimization, and pain risk assessment.

The researchers reported having no financial disclosures.

dbrunk@frontlinemedcom.com

SAN DIEGO – Nearly one-third of pain-related emergency room visits or hospital readmissions following same-day surgery were attributable to inadequate pain management in the peridischarge period, a large single-center analysis demonstrated.

“Pain management in the perioperative period is largely an anesthesiologist responsibility, but maybe it would be helpful if it was a little bit more multispecialty, if we had more communication,” study author Dr. Martha O. Herbst said in an interview at the annual meeting of the American Society of Anesthesiologists.

“There were some patients who came back for pain because they didn’t even receive prescriptions from their surgeon. Maybe a little better communication between the anesthesiologist and the surgeon on how to optimize specific patients and prevent those readmissions for pain would help,” she said.

Inspired by a similar study published in 2002 (J Clin Anesth. 2002;14[5]:349-53), Dr. Herbst, a fourth-year anesthesiology resident at Beaumont Hospital in Royal Oak, Mich., and her associates retrospectively evaluated the number of readmissions or revisits that occurred among 28,647 patients who underwent same-day surgery in the Beaumont Health system in 2012. A total of 1,559 revisits occurred during the study period. Of these, 621 (39.8%) were revisits related to the surgical procedure and 145 (9.3% overall and 23.3% of readmissions) were due to pain.

The researchers then stratified patients into one of six categories for readmission. These included all-cause pain (16%); surgical-related issues such as wound opening or reinfection (21%); medical issues such as exacerbation of chronic obstructive pulmonary disease (43%); bleeding complications such as hematuria, hemodialysis, and surgical site bleeding (6%); adverse medical reactions (2%); and other (12%).

Of the 145 patients who were readmitted for pain from the same-day surgery, 71% were deemed to have no pre-existing risk for readmission while 29% had at least one risk factor for readmission. These included opioid monotherapy during the procedure (11%), history of chronic pain (9%), no pain medication given during the procedure (4%), inadequate doses of analgesics used (3%), and discharge without a prescription for an analgesic (2%).

“There were people who got tiny doses of pain medications after a huge, painful procedure, so that was surprising,” Dr. Herbst said. “Maybe they weren’t optimally managed at the time of surgery.”

The findings, she concluded, underscore the need for a team-based approach to pain management in the same-day surgery population, with discharge planning focused on patient education, expectation management, multimodal analgesia optimization, and pain risk assessment.

The researchers reported having no financial disclosures.

dbrunk@frontlinemedcom.com

SAN DIEGO – If you feel sleepy and out of sorts on a post-call day, compared with a normal work day, you’re not alone.

Anesthesiology faculty reported significant increases in feeling irritable, jittery, and sleepy, along with significant decreases in feeling confident, energetic, and talkative following an on-call period, according to a study presented at the annual meeting of the American Society of Anesthesiologists.

To date, most studies of partial sleep deprivation in health care settings have focused on residents and interns, and less on medical faculty, said lead study author Dr. Haleh Saadat of the department of anesthesiology and pain medicine at Nationwide Children’s Hospital in Columbus, Ohio. “Our call is 17 hours, from 3 p.m. to 7 a.m.; but the call period at most hospitals is 24 hours, and even longer at some private practices,” she said in an interview.

To examine the effects of partial sleep deprivation on reaction time, simple cognitive skills , and mood status in 21 anesthesiologists, Dr. Saadat and her associates obtained verbal consent from the study participants and measured reaction time, mood states, and eight subjective behavioral characteristics at two different time points: between 6:30 a.m. and 8 a.m. on a regular noncall day of work, and between 6:30 a.m. and 8 a.m. after an overnight call (a shift that runs from 3 p.m. to 7 a.m.). The behavioral characteristics included feeling alert, energetic, anxious, confident, irritable, jittery/nervous, sleepy, and talkative, and the researchers used paired t-tests to compare variable means between regular sleep days and post-call days.

Reaction time decreased in all 21 subjects after night call, indicating worse performance (P = 0.047), while total mood disturbance was significantly higher on post-call days, relative to noncall days (P less than 0.001).

Of the 21 anesthesiologists, 19 completed all simple cognitive task questions at both time points and reported significant increases in several of these parameters on post-call days, compared with normal work days.

Post-call observations found participants feeling more irritable, confident, energetic, sleepy (P less than .001), feeling more jittery (P = .003), and feeling less talkative (P less than .001) than on normal work days.

Coping strategies used to address their sleep deprivation were measured as well, with “most of our subjects using problem solving, followed by seeking social support and avoidance,” Dr. Saadat noted. “People who used avoidance had greater declines in reaction time on post-call days, compared with the rest of the study participants. It didn’t matter whether you were male, female, younger, or older.”

Dr. Saadat called for additional studies to evaluate the neurocognitive impact of partial sleep deprivation on physicians’ on-call duties.

“I would like to see if we can replicate the results in bigger centers,” she said. “If this is what is happening, we may need to pay more attention to faculty’s work hours in both academic and private practice settings – not only among anesthesiologists, but also in other specialties. These observations require a closer look at the potential implications for patients’ and professionals’ safety.”

The researchers reported no financial disclosures.

dbrunk@frontlinemedcom.com

SAN DIEGO – If you feel sleepy and out of sorts on a post-call day, compared with a normal work day, you’re not alone.

Anesthesiology faculty reported significant increases in feeling irritable, jittery, and sleepy, along with significant decreases in feeling confident, energetic, and talkative following an on-call period, according to a study presented at the annual meeting of the American Society of Anesthesiologists.

To date, most studies of partial sleep deprivation in health care settings have focused on residents and interns, and less on medical faculty, said lead study author Dr. Haleh Saadat of the department of anesthesiology and pain medicine at Nationwide Children’s Hospital in Columbus, Ohio. “Our call is 17 hours, from 3 p.m. to 7 a.m.; but the call period at most hospitals is 24 hours, and even longer at some private practices,” she said in an interview.

To examine the effects of partial sleep deprivation on reaction time, simple cognitive skills , and mood status in 21 anesthesiologists, Dr. Saadat and her associates obtained verbal consent from the study participants and measured reaction time, mood states, and eight subjective behavioral characteristics at two different time points: between 6:30 a.m. and 8 a.m. on a regular noncall day of work, and between 6:30 a.m. and 8 a.m. after an overnight call (a shift that runs from 3 p.m. to 7 a.m.). The behavioral characteristics included feeling alert, energetic, anxious, confident, irritable, jittery/nervous, sleepy, and talkative, and the researchers used paired t-tests to compare variable means between regular sleep days and post-call days.

Reaction time decreased in all 21 subjects after night call, indicating worse performance (P = 0.047), while total mood disturbance was significantly higher on post-call days, relative to noncall days (P less than 0.001).

Of the 21 anesthesiologists, 19 completed all simple cognitive task questions at both time points and reported significant increases in several of these parameters on post-call days, compared with normal work days.

Post-call observations found participants feeling more irritable, confident, energetic, sleepy (P less than .001), feeling more jittery (P = .003), and feeling less talkative (P less than .001) than on normal work days.

Coping strategies used to address their sleep deprivation were measured as well, with “most of our subjects using problem solving, followed by seeking social support and avoidance,” Dr. Saadat noted. “People who used avoidance had greater declines in reaction time on post-call days, compared with the rest of the study participants. It didn’t matter whether you were male, female, younger, or older.”

Dr. Saadat called for additional studies to evaluate the neurocognitive impact of partial sleep deprivation on physicians’ on-call duties.

“I would like to see if we can replicate the results in bigger centers,” she said. “If this is what is happening, we may need to pay more attention to faculty’s work hours in both academic and private practice settings – not only among anesthesiologists, but also in other specialties. These observations require a closer look at the potential implications for patients’ and professionals’ safety.”

The researchers reported no financial disclosures.

dbrunk@frontlinemedcom.com

SAN DIEGO – If you feel sleepy and out of sorts on a post-call day, compared with a normal work day, you’re not alone.

Anesthesiology faculty reported significant increases in feeling irritable, jittery, and sleepy, along with significant decreases in feeling confident, energetic, and talkative following an on-call period, according to a study presented at the annual meeting of the American Society of Anesthesiologists.

To date, most studies of partial sleep deprivation in health care settings have focused on residents and interns, and less on medical faculty, said lead study author Dr. Haleh Saadat of the department of anesthesiology and pain medicine at Nationwide Children’s Hospital in Columbus, Ohio. “Our call is 17 hours, from 3 p.m. to 7 a.m.; but the call period at most hospitals is 24 hours, and even longer at some private practices,” she said in an interview.

To examine the effects of partial sleep deprivation on reaction time, simple cognitive skills , and mood status in 21 anesthesiologists, Dr. Saadat and her associates obtained verbal consent from the study participants and measured reaction time, mood states, and eight subjective behavioral characteristics at two different time points: between 6:30 a.m. and 8 a.m. on a regular noncall day of work, and between 6:30 a.m. and 8 a.m. after an overnight call (a shift that runs from 3 p.m. to 7 a.m.). The behavioral characteristics included feeling alert, energetic, anxious, confident, irritable, jittery/nervous, sleepy, and talkative, and the researchers used paired t-tests to compare variable means between regular sleep days and post-call days.

Reaction time decreased in all 21 subjects after night call, indicating worse performance (P = 0.047), while total mood disturbance was significantly higher on post-call days, relative to noncall days (P less than 0.001).

Of the 21 anesthesiologists, 19 completed all simple cognitive task questions at both time points and reported significant increases in several of these parameters on post-call days, compared with normal work days.

Post-call observations found participants feeling more irritable, confident, energetic, sleepy (P less than .001), feeling more jittery (P = .003), and feeling less talkative (P less than .001) than on normal work days.

Coping strategies used to address their sleep deprivation were measured as well, with “most of our subjects using problem solving, followed by seeking social support and avoidance,” Dr. Saadat noted. “People who used avoidance had greater declines in reaction time on post-call days, compared with the rest of the study participants. It didn’t matter whether you were male, female, younger, or older.”

Dr. Saadat called for additional studies to evaluate the neurocognitive impact of partial sleep deprivation on physicians’ on-call duties.

“I would like to see if we can replicate the results in bigger centers,” she said. “If this is what is happening, we may need to pay more attention to faculty’s work hours in both academic and private practice settings – not only among anesthesiologists, but also in other specialties. These observations require a closer look at the potential implications for patients’ and professionals’ safety.”

The researchers reported no financial disclosures.

dbrunk@frontlinemedcom.com

SAN DIEGO – Patients with chronic low back pain who report pain scores that do not correlate well with their functional activity level are less satisfied with their pain management treatment, a single-center study found.

“Taking into account that the Affordable Healthcare Act is planning to base physician reimbursements on patient satisfaction with provided treatment, it is imperative to educate patients regarding the necessity to accurately report their pain level using a numeric rating scale. We must also identify other parameters in defining our patients’ chronic pain conditions, such a functionality scales and quality of life questionnaires,” Dr. Nebojsa Nick Knezevic said at the annual meeting of the American Society of Anesthesiologists.

“We rely on many different types of scales for pain, including Likert scales, visual analog scales, and numerical pain rating scales,” said Dr. Knezevic, vice chair for research and education at Advocate Illinois Masonic Medical Center, Chicago. “However, there are many reports talking about the subjectivity of these scales. Interpretation of the pain scores can underestimate or overestimate patient conditions, and they may go on to receive treatments that are not indicated.”

In an effort to assess how numeric pain scores reported by patients with chronic low back pain correlate with their functional activity levels and satisfaction with their pain management, Dr. Knezevic and his associates enrolled 100 patients with radicular low back pain and a mean age of 49 years. Overall, 56% were female, and their average duration of low back pain prior to study enrollment was 14 months.

The investigators asked them to complete pain scores on an 11-point numeric rating scale at rest and during movement, as well as the Oswestry Disability Index (ODI) questionnaire. The researchers evaluated the patients 10 times over a 1-year period at the same time points and asked them to grade their satisfaction with pain management on a scale from 1 to 5, where 1 meant completely dissatisfied, 2 meant dissatisfied, 3 meant somewhat satisfied, 4 meant satisfied, and 5 meant completely satisfied. The investigators multiplied the pain scores by 10 to be on the same 0-100 scale as the ODI and compared the values at each visit. Differences between the ODI and pain scores in the range of –10% to +10% were considered normal, while differences between 11% and 30% were considered mild, differences between 31% and 50% were considered moderate, and differences of more than 50% were considered severe.

Dr. Knezevic reported that pain scores at rest correlated well with ODI in 65% of patients, while mild discrepancies were present in 30% of patients, moderate discrepancies in 4%, and severe discrepancies in 1%. On the other hand, pain scores during movement correlated well with ODI in only 39% of patients, while mild discrepancies were present in 42% of patients, moderate discrepancies in 14%, and severe discrepancies in 5%. More than half of patients (58%) reported pain levels during movement that did not correlate with the level of functional activity indicated by their ODI score. However, inconsistencies between male and female pain score reporting at rest and during movement were equal (P = .606 and P = .928, respectively).

The researchers also found that patients who were taking opioids showed greater discrepancy in reporting pain intensity scores, compared with patients using nonopioid analgesics, as well as those who were not taking medications for their low back pain (P = .038).

“Results of this study showed negative correlation between the degree of discrepancy in pain scores and patient satisfaction with pain management treatment,” Dr. Knezevic concluded.

Dr. Knezevic reported having no financial disclosures.

dbrunk@frontlinemedcom.com

SAN DIEGO – Patients with chronic low back pain who report pain scores that do not correlate well with their functional activity level are less satisfied with their pain management treatment, a single-center study found.

“Taking into account that the Affordable Healthcare Act is planning to base physician reimbursements on patient satisfaction with provided treatment, it is imperative to educate patients regarding the necessity to accurately report their pain level using a numeric rating scale. We must also identify other parameters in defining our patients’ chronic pain conditions, such a functionality scales and quality of life questionnaires,” Dr. Nebojsa Nick Knezevic said at the annual meeting of the American Society of Anesthesiologists.

“We rely on many different types of scales for pain, including Likert scales, visual analog scales, and numerical pain rating scales,” said Dr. Knezevic, vice chair for research and education at Advocate Illinois Masonic Medical Center, Chicago. “However, there are many reports talking about the subjectivity of these scales. Interpretation of the pain scores can underestimate or overestimate patient conditions, and they may go on to receive treatments that are not indicated.”

In an effort to assess how numeric pain scores reported by patients with chronic low back pain correlate with their functional activity levels and satisfaction with their pain management, Dr. Knezevic and his associates enrolled 100 patients with radicular low back pain and a mean age of 49 years. Overall, 56% were female, and their average duration of low back pain prior to study enrollment was 14 months.

The investigators asked them to complete pain scores on an 11-point numeric rating scale at rest and during movement, as well as the Oswestry Disability Index (ODI) questionnaire. The researchers evaluated the patients 10 times over a 1-year period at the same time points and asked them to grade their satisfaction with pain management on a scale from 1 to 5, where 1 meant completely dissatisfied, 2 meant dissatisfied, 3 meant somewhat satisfied, 4 meant satisfied, and 5 meant completely satisfied. The investigators multiplied the pain scores by 10 to be on the same 0-100 scale as the ODI and compared the values at each visit. Differences between the ODI and pain scores in the range of –10% to +10% were considered normal, while differences between 11% and 30% were considered mild, differences between 31% and 50% were considered moderate, and differences of more than 50% were considered severe.

Dr. Knezevic reported that pain scores at rest correlated well with ODI in 65% of patients, while mild discrepancies were present in 30% of patients, moderate discrepancies in 4%, and severe discrepancies in 1%. On the other hand, pain scores during movement correlated well with ODI in only 39% of patients, while mild discrepancies were present in 42% of patients, moderate discrepancies in 14%, and severe discrepancies in 5%. More than half of patients (58%) reported pain levels during movement that did not correlate with the level of functional activity indicated by their ODI score. However, inconsistencies between male and female pain score reporting at rest and during movement were equal (P = .606 and P = .928, respectively).

The researchers also found that patients who were taking opioids showed greater discrepancy in reporting pain intensity scores, compared with patients using nonopioid analgesics, as well as those who were not taking medications for their low back pain (P = .038).

“Results of this study showed negative correlation between the degree of discrepancy in pain scores and patient satisfaction with pain management treatment,” Dr. Knezevic concluded.

Dr. Knezevic reported having no financial disclosures.

dbrunk@frontlinemedcom.com

SAN DIEGO – Patients with chronic low back pain who report pain scores that do not correlate well with their functional activity level are less satisfied with their pain management treatment, a single-center study found.

“Taking into account that the Affordable Healthcare Act is planning to base physician reimbursements on patient satisfaction with provided treatment, it is imperative to educate patients regarding the necessity to accurately report their pain level using a numeric rating scale. We must also identify other parameters in defining our patients’ chronic pain conditions, such a functionality scales and quality of life questionnaires,” Dr. Nebojsa Nick Knezevic said at the annual meeting of the American Society of Anesthesiologists.

“We rely on many different types of scales for pain, including Likert scales, visual analog scales, and numerical pain rating scales,” said Dr. Knezevic, vice chair for research and education at Advocate Illinois Masonic Medical Center, Chicago. “However, there are many reports talking about the subjectivity of these scales. Interpretation of the pain scores can underestimate or overestimate patient conditions, and they may go on to receive treatments that are not indicated.”

In an effort to assess how numeric pain scores reported by patients with chronic low back pain correlate with their functional activity levels and satisfaction with their pain management, Dr. Knezevic and his associates enrolled 100 patients with radicular low back pain and a mean age of 49 years. Overall, 56% were female, and their average duration of low back pain prior to study enrollment was 14 months.

The investigators asked them to complete pain scores on an 11-point numeric rating scale at rest and during movement, as well as the Oswestry Disability Index (ODI) questionnaire. The researchers evaluated the patients 10 times over a 1-year period at the same time points and asked them to grade their satisfaction with pain management on a scale from 1 to 5, where 1 meant completely dissatisfied, 2 meant dissatisfied, 3 meant somewhat satisfied, 4 meant satisfied, and 5 meant completely satisfied. The investigators multiplied the pain scores by 10 to be on the same 0-100 scale as the ODI and compared the values at each visit. Differences between the ODI and pain scores in the range of –10% to +10% were considered normal, while differences between 11% and 30% were considered mild, differences between 31% and 50% were considered moderate, and differences of more than 50% were considered severe.

Dr. Knezevic reported that pain scores at rest correlated well with ODI in 65% of patients, while mild discrepancies were present in 30% of patients, moderate discrepancies in 4%, and severe discrepancies in 1%. On the other hand, pain scores during movement correlated well with ODI in only 39% of patients, while mild discrepancies were present in 42% of patients, moderate discrepancies in 14%, and severe discrepancies in 5%. More than half of patients (58%) reported pain levels during movement that did not correlate with the level of functional activity indicated by their ODI score. However, inconsistencies between male and female pain score reporting at rest and during movement were equal (P = .606 and P = .928, respectively).

The researchers also found that patients who were taking opioids showed greater discrepancy in reporting pain intensity scores, compared with patients using nonopioid analgesics, as well as those who were not taking medications for their low back pain (P = .038).

“Results of this study showed negative correlation between the degree of discrepancy in pain scores and patient satisfaction with pain management treatment,” Dr. Knezevic concluded.

Dr. Knezevic reported having no financial disclosures.

dbrunk@frontlinemedcom.com

SAN DIEGO – Among patients with advanced chronic kidney disease (CKD) and type 2 diabetes, a shift in gut microbiota in combination with plasma zonulin may be linked with chronic inflammation and endothelial dysfunction, according to results from an observational study.

“Diabetes patients have compromised gut microbiome due to metabolic disorder,” lead study author Ruchi Singh, Ph.D., said in an interview in advance of Kidney Week 2015. “Due to their hyperglycemic condition they have chronic inflammation and endothelial dysfunction as a baseline. They do have increased gut permeability. Therefore, a change in gut microbiome may have a high impact on this patient population.”

For the study, Dr. Singh, a postdoctoral research associate at Texas Tech University Health Sciences Center, Amarillo, and her associates used 16S ribosomal RNA sequencing and quantitative analysis to evaluate the composition of gut microbiota in 40 patients with CKD and diabetic neuropathy, including 20 age- and gender-matched controls. Markers of interest included serum zonulin, tumor necrosis factor–alpha (TNF-alpha), interleuikin-6 (IL-6), fibroblast growth factor 23 (FGF-23; which is considered to be strongly correlated with cardiovascular health), endothelin 1 (ET-1), and levels of lipopolysaccharide (LPS). The mean age of patients was 59 years, and 38% were male.

Compared with controls matched for age, gender, and diet, CKD patients with diabetes had significantly higher circulating levels of all studied markers except IL-6. “The biggest surprise was that zonulin was positively correlated with FGF-23,” Dr. Singh said. “We do not have a good explanation for this at the moment and further investigation needed is to answer this.”

Zonulin was also positively correlated with TNF-alpha, IL-6, and LPS. “We hope to use zonulin as a therapeutic target which might prevent further progression of chronic kidney disease and improve cardiac health,” she said.

The researchers also observed “a huge difference in microbiome profile of healthy and CKD patients. We are going to look further in microbiome profile and see which bacterial group could have most impact on gut permeability and inflammation.”

Dr. Singh acknowledged certain limitations of the study, including its observational design and the fact that only patients with advanced CKD and multiple comorbidities were included, “which could impact our findings. In future we would like to design a prospective, targeted interventional study.”

The study was funded in part by a postdoctoral training grant from Sanofi/Genzyme. Study author and a mentor of the project, Dr. Tetyana L. Vasylyeva, disclosed that she is a scientific advisor for Alexion. Dr. Singh reported having no financial disclosures. Kidney Week 2015 is sponsored by the American Society of Nephrology.

SAN DIEGO – Among patients with advanced chronic kidney disease (CKD) and type 2 diabetes, a shift in gut microbiota in combination with plasma zonulin may be linked with chronic inflammation and endothelial dysfunction, according to results from an observational study.

“Diabetes patients have compromised gut microbiome due to metabolic disorder,” lead study author Ruchi Singh, Ph.D., said in an interview in advance of Kidney Week 2015. “Due to their hyperglycemic condition they have chronic inflammation and endothelial dysfunction as a baseline. They do have increased gut permeability. Therefore, a change in gut microbiome may have a high impact on this patient population.”

For the study, Dr. Singh, a postdoctoral research associate at Texas Tech University Health Sciences Center, Amarillo, and her associates used 16S ribosomal RNA sequencing and quantitative analysis to evaluate the composition of gut microbiota in 40 patients with CKD and diabetic neuropathy, including 20 age- and gender-matched controls. Markers of interest included serum zonulin, tumor necrosis factor–alpha (TNF-alpha), interleuikin-6 (IL-6), fibroblast growth factor 23 (FGF-23; which is considered to be strongly correlated with cardiovascular health), endothelin 1 (ET-1), and levels of lipopolysaccharide (LPS). The mean age of patients was 59 years, and 38% were male.

Compared with controls matched for age, gender, and diet, CKD patients with diabetes had significantly higher circulating levels of all studied markers except IL-6. “The biggest surprise was that zonulin was positively correlated with FGF-23,” Dr. Singh said. “We do not have a good explanation for this at the moment and further investigation needed is to answer this.”

Zonulin was also positively correlated with TNF-alpha, IL-6, and LPS. “We hope to use zonulin as a therapeutic target which might prevent further progression of chronic kidney disease and improve cardiac health,” she said.

The researchers also observed “a huge difference in microbiome profile of healthy and CKD patients. We are going to look further in microbiome profile and see which bacterial group could have most impact on gut permeability and inflammation.”

Dr. Singh acknowledged certain limitations of the study, including its observational design and the fact that only patients with advanced CKD and multiple comorbidities were included, “which could impact our findings. In future we would like to design a prospective, targeted interventional study.”

The study was funded in part by a postdoctoral training grant from Sanofi/Genzyme. Study author and a mentor of the project, Dr. Tetyana L. Vasylyeva, disclosed that she is a scientific advisor for Alexion. Dr. Singh reported having no financial disclosures. Kidney Week 2015 is sponsored by the American Society of Nephrology.

SAN DIEGO – Among patients with advanced chronic kidney disease (CKD) and type 2 diabetes, a shift in gut microbiota in combination with plasma zonulin may be linked with chronic inflammation and endothelial dysfunction, according to results from an observational study.

“Diabetes patients have compromised gut microbiome due to metabolic disorder,” lead study author Ruchi Singh, Ph.D., said in an interview in advance of Kidney Week 2015. “Due to their hyperglycemic condition they have chronic inflammation and endothelial dysfunction as a baseline. They do have increased gut permeability. Therefore, a change in gut microbiome may have a high impact on this patient population.”

For the study, Dr. Singh, a postdoctoral research associate at Texas Tech University Health Sciences Center, Amarillo, and her associates used 16S ribosomal RNA sequencing and quantitative analysis to evaluate the composition of gut microbiota in 40 patients with CKD and diabetic neuropathy, including 20 age- and gender-matched controls. Markers of interest included serum zonulin, tumor necrosis factor–alpha (TNF-alpha), interleuikin-6 (IL-6), fibroblast growth factor 23 (FGF-23; which is considered to be strongly correlated with cardiovascular health), endothelin 1 (ET-1), and levels of lipopolysaccharide (LPS). The mean age of patients was 59 years, and 38% were male.

Compared with controls matched for age, gender, and diet, CKD patients with diabetes had significantly higher circulating levels of all studied markers except IL-6. “The biggest surprise was that zonulin was positively correlated with FGF-23,” Dr. Singh said. “We do not have a good explanation for this at the moment and further investigation needed is to answer this.”

Zonulin was also positively correlated with TNF-alpha, IL-6, and LPS. “We hope to use zonulin as a therapeutic target which might prevent further progression of chronic kidney disease and improve cardiac health,” she said.

The researchers also observed “a huge difference in microbiome profile of healthy and CKD patients. We are going to look further in microbiome profile and see which bacterial group could have most impact on gut permeability and inflammation.”

Dr. Singh acknowledged certain limitations of the study, including its observational design and the fact that only patients with advanced CKD and multiple comorbidities were included, “which could impact our findings. In future we would like to design a prospective, targeted interventional study.”

The study was funded in part by a postdoctoral training grant from Sanofi/Genzyme. Study author and a mentor of the project, Dr. Tetyana L. Vasylyeva, disclosed that she is a scientific advisor for Alexion. Dr. Singh reported having no financial disclosures. Kidney Week 2015 is sponsored by the American Society of Nephrology.

SAN DIEGO – Among patients with advanced chronic kidney disease (CKD) and type 2 diabetes, a shift in gut microbiota in combination with plasma zonulin may be linked with chronic inflammation and endothelial dysfunction, according to results from an observational study.

“Diabetes patients have compromised gut microbiome due to metabolic disorder,” lead study author Ruchi Singh, Ph.D., said in an interview in advance of Kidney Week 2015. “Due to their hyperglycemic condition they have chronic inflammation and endothelial dysfunction as a baseline. They do have increased gut permeability. Therefore, a change in gut microbiome may have a high impact on this patient population.”

For the study, Dr. Singh, a postdoctoral research associate at Texas Tech University Health Sciences Center, Amarillo, and her associates used 16S ribosomal RNA sequencing and quantitative analysis to evaluate the composition of gut microbiota in 40 patients with CKD and diabetic neuropathy, including 20 age- and gender-matched controls. Markers of interest included serum zonulin, tumor necrosis factor–alpha (TNF-alpha), interleuikin-6 (IL-6), fibroblast growth factor 23 (FGF-23; which is considered to be strongly correlated with cardiovascular health), endothelin 1 (ET-1), and levels of lipopolysaccharide (LPS). The mean age of patients was 59 years, and 38% were male.

Compared with controls matched for age, gender, and diet, CKD patients with diabetes had significantly higher circulating levels of all studied markers except IL-6. “The biggest surprise was that zonulin was positively correlated with FGF-23,” Dr. Singh said. “We do not have a good explanation for this at the moment and further investigation needed is to answer this.”

Zonulin was also positively correlated with TNF-alpha, IL-6, and LPS. “We hope to use zonulin as a therapeutic target which might prevent further progression of chronic kidney disease and improve cardiac health,” she said.

The researchers also observed “a huge difference in microbiome profile of healthy and CKD patients. We are going to look further in microbiome profile and see which bacterial group could have most impact on gut permeability and inflammation.”

Dr. Singh acknowledged certain limitations of the study, including its observational design and the fact that only patients with advanced CKD and multiple comorbidities were included, “which could impact our findings. In future we would like to design a prospective, targeted interventional study.”

The study was funded in part by a postdoctoral training grant from Sanofi/Genzyme. Study author and a mentor of the project, Dr. Tetyana L. Vasylyeva, disclosed that she is a scientific advisor for Alexion. Dr. Singh reported having no financial disclosures. Kidney Week 2015 is sponsored by the American Society of Nephrology.

dbrunk@frontlinemedcom.com

SAN DIEGO – Among patients with advanced chronic kidney disease (CKD) and type 2 diabetes, a shift in gut microbiota in combination with plasma zonulin may be linked with chronic inflammation and endothelial dysfunction, according to results from an observational study.

“Diabetes patients have compromised gut microbiome due to metabolic disorder,” lead study author Ruchi Singh, Ph.D., said in an interview in advance of Kidney Week 2015. “Due to their hyperglycemic condition they have chronic inflammation and endothelial dysfunction as a baseline. They do have increased gut permeability. Therefore, a change in gut microbiome may have a high impact on this patient population.”

For the study, Dr. Singh, a postdoctoral research associate at Texas Tech University Health Sciences Center, Amarillo, and her associates used 16S ribosomal RNA sequencing and quantitative analysis to evaluate the composition of gut microbiota in 40 patients with CKD and diabetic neuropathy, including 20 age- and gender-matched controls. Markers of interest included serum zonulin, tumor necrosis factor–alpha (TNF-alpha), interleuikin-6 (IL-6), fibroblast growth factor 23 (FGF-23; which is considered to be strongly correlated with cardiovascular health), endothelin 1 (ET-1), and levels of lipopolysaccharide (LPS). The mean age of patients was 59 years, and 38% were male.

Compared with controls matched for age, gender, and diet, CKD patients with diabetes had significantly higher circulating levels of all studied markers except IL-6. “The biggest surprise was that zonulin was positively correlated with FGF-23,” Dr. Singh said. “We do not have a good explanation for this at the moment and further investigation needed is to answer this.”

Zonulin was also positively correlated with TNF-alpha, IL-6, and LPS. “We hope to use zonulin as a therapeutic target which might prevent further progression of chronic kidney disease and improve cardiac health,” she said.

The researchers also observed “a huge difference in microbiome profile of healthy and CKD patients. We are going to look further in microbiome profile and see which bacterial group could have most impact on gut permeability and inflammation.”

Dr. Singh acknowledged certain limitations of the study, including its observational design and the fact that only patients with advanced CKD and multiple comorbidities were included, “which could impact our findings. In future we would like to design a prospective, targeted interventional study.”

The study was funded in part by a postdoctoral training grant from Sanofi/Genzyme. Study author and a mentor of the project, Dr. Tetyana L. Vasylyeva, disclosed that she is a scientific advisor for Alexion. Dr. Singh reported having no financial disclosures. Kidney Week 2015 is sponsored by the American Society of Nephrology.

dbrunk@frontlinemedcom.com

SAN DIEGO – Among patients with advanced chronic kidney disease (CKD) and type 2 diabetes, a shift in gut microbiota in combination with plasma zonulin may be linked with chronic inflammation and endothelial dysfunction, according to results from an observational study.

“Diabetes patients have compromised gut microbiome due to metabolic disorder,” lead study author Ruchi Singh, Ph.D., said in an interview in advance of Kidney Week 2015. “Due to their hyperglycemic condition they have chronic inflammation and endothelial dysfunction as a baseline. They do have increased gut permeability. Therefore, a change in gut microbiome may have a high impact on this patient population.”

For the study, Dr. Singh, a postdoctoral research associate at Texas Tech University Health Sciences Center, Amarillo, and her associates used 16S ribosomal RNA sequencing and quantitative analysis to evaluate the composition of gut microbiota in 40 patients with CKD and diabetic neuropathy, including 20 age- and gender-matched controls. Markers of interest included serum zonulin, tumor necrosis factor–alpha (TNF-alpha), interleuikin-6 (IL-6), fibroblast growth factor 23 (FGF-23; which is considered to be strongly correlated with cardiovascular health), endothelin 1 (ET-1), and levels of lipopolysaccharide (LPS). The mean age of patients was 59 years, and 38% were male.

Compared with controls matched for age, gender, and diet, CKD patients with diabetes had significantly higher circulating levels of all studied markers except IL-6. “The biggest surprise was that zonulin was positively correlated with FGF-23,” Dr. Singh said. “We do not have a good explanation for this at the moment and further investigation needed is to answer this.”

Zonulin was also positively correlated with TNF-alpha, IL-6, and LPS. “We hope to use zonulin as a therapeutic target which might prevent further progression of chronic kidney disease and improve cardiac health,” she said.

The researchers also observed “a huge difference in microbiome profile of healthy and CKD patients. We are going to look further in microbiome profile and see which bacterial group could have most impact on gut permeability and inflammation.”

Dr. Singh acknowledged certain limitations of the study, including its observational design and the fact that only patients with advanced CKD and multiple comorbidities were included, “which could impact our findings. In future we would like to design a prospective, targeted interventional study.”

The study was funded in part by a postdoctoral training grant from Sanofi/Genzyme. Study author and a mentor of the project, Dr. Tetyana L. Vasylyeva, disclosed that she is a scientific advisor for Alexion. Dr. Singh reported having no financial disclosures. Kidney Week 2015 is sponsored by the American Society of Nephrology.

dbrunk@frontlinemedcom.com

SAN DIEGO – A streamlined approach to the management of acute kidney injury led to a reduction in mortality rates and hospital length of stay, results from an observational study demonstrated.

“We can make significant improvement in AKI outcomes using simple interventions: risk assessment for AKI, medicine management for those at risk, an automated e-alert to ensure early detection that triggers an intervention bundle implemented by frontline staff, rapid referral to and review by nephrology, and empowering patients and caregivers to minimize risk,” study coauthor Dr. Thangavelu Chandrasekar said in an interview in advance of Kidney Week 2015.

Dr. Chandrasekar of the nephrology department at Aintree University Hospital, Liverpool, England, noted that AKI has a mortality rate of 30%, which is higher than that for myocardial infarction (8%) and stroke (9%). In their abstract, he and study coauthor Dr. Hsu Pheen Chong estimated that 15% of all inpatients at Aintree University Hospital suffer an AKI, “making it a condition of considerable importance in everyday practice.”

In an effort to reduce AKI mortality by 30% and length of stay by 20% at the hospital, the researchers used Plan-Do-Study-Act methodology to develop a project known as STOP-AKI.

Launched in October 2013, STOP-AKI consists of:

• A risk assessment for AKI in all medical admissions, with increased surveillance and medicine management for those at risk.

• An automated real-time electronic alert to ensure early detection that triggers an intervention bundle implemented by frontline staff who target any deteriorating patient.

• Rapid referral to and review by nephrology in patients who required renal inputs.

• The conveyance of verbal and written information about AKI to patients and their caregivers.

STOP-AKI was initially launched in the nephrology ward and then scaled up to become part of routine management for all patients admitted to the hospital.

The researchers found that from October 2013 through September 2015, AKI mortality rates fell from a baseline of 26% to 19%, which represented an overall reduction in mortality of 27%. At the same time, hospital length of stay fell by 13%, which amounted to a 2.7-day reduction in length of stay.

“Early identification and intervention are the key factors [in treating AKI],” Dr. Chandrasekar said. “Our study is proof for this, which has shown a significant drop in mortality and reduction in length of stay in hospitalized patients.

“We used a whole system approach with multiple interventions at different levels that dovetail with each other and [are] designed to empower health care professionals, including [the] most junior person to intervene effectively,” he added.

Dr. Chandrasekar and his associates are developing metrics to assess AKI progression and its predictors.

The researchers reported having no financial disclosures. The meeting was sponsored by the American Society of Nephrology.

dbrunk@frontlinemedcom.com

SAN DIEGO – A streamlined approach to the management of acute kidney injury led to a reduction in mortality rates and hospital length of stay, results from an observational study demonstrated.

“We can make significant improvement in AKI outcomes using simple interventions: risk assessment for AKI, medicine management for those at risk, an automated e-alert to ensure early detection that triggers an intervention bundle implemented by frontline staff, rapid referral to and review by nephrology, and empowering patients and caregivers to minimize risk,” study coauthor Dr. Thangavelu Chandrasekar said in an interview in advance of Kidney Week 2015.

Dr. Chandrasekar of the nephrology department at Aintree University Hospital, Liverpool, England, noted that AKI has a mortality rate of 30%, which is higher than that for myocardial infarction (8%) and stroke (9%). In their abstract, he and study coauthor Dr. Hsu Pheen Chong estimated that 15% of all inpatients at Aintree University Hospital suffer an AKI, “making it a condition of considerable importance in everyday practice.”

In an effort to reduce AKI mortality by 30% and length of stay by 20% at the hospital, the researchers used Plan-Do-Study-Act methodology to develop a project known as STOP-AKI.

Launched in October 2013, STOP-AKI consists of:

• A risk assessment for AKI in all medical admissions, with increased surveillance and medicine management for those at risk.

• An automated real-time electronic alert to ensure early detection that triggers an intervention bundle implemented by frontline staff who target any deteriorating patient.

• Rapid referral to and review by nephrology in patients who required renal inputs.

• The conveyance of verbal and written information about AKI to patients and their caregivers.

STOP-AKI was initially launched in the nephrology ward and then scaled up to become part of routine management for all patients admitted to the hospital.

The researchers found that from October 2013 through September 2015, AKI mortality rates fell from a baseline of 26% to 19%, which represented an overall reduction in mortality of 27%. At the same time, hospital length of stay fell by 13%, which amounted to a 2.7-day reduction in length of stay.

“Early identification and intervention are the key factors [in treating AKI],” Dr. Chandrasekar said. “Our study is proof for this, which has shown a significant drop in mortality and reduction in length of stay in hospitalized patients.

“We used a whole system approach with multiple interventions at different levels that dovetail with each other and [are] designed to empower health care professionals, including [the] most junior person to intervene effectively,” he added.

Dr. Chandrasekar and his associates are developing metrics to assess AKI progression and its predictors.

The researchers reported having no financial disclosures. The meeting was sponsored by the American Society of Nephrology.

dbrunk@frontlinemedcom.com

SAN DIEGO – A streamlined approach to the management of acute kidney injury led to a reduction in mortality rates and hospital length of stay, results from an observational study demonstrated.

“We can make significant improvement in AKI outcomes using simple interventions: risk assessment for AKI, medicine management for those at risk, an automated e-alert to ensure early detection that triggers an intervention bundle implemented by frontline staff, rapid referral to and review by nephrology, and empowering patients and caregivers to minimize risk,” study coauthor Dr. Thangavelu Chandrasekar said in an interview in advance of Kidney Week 2015.

Dr. Chandrasekar of the nephrology department at Aintree University Hospital, Liverpool, England, noted that AKI has a mortality rate of 30%, which is higher than that for myocardial infarction (8%) and stroke (9%). In their abstract, he and study coauthor Dr. Hsu Pheen Chong estimated that 15% of all inpatients at Aintree University Hospital suffer an AKI, “making it a condition of considerable importance in everyday practice.”

In an effort to reduce AKI mortality by 30% and length of stay by 20% at the hospital, the researchers used Plan-Do-Study-Act methodology to develop a project known as STOP-AKI.

Launched in October 2013, STOP-AKI consists of:

• A risk assessment for AKI in all medical admissions, with increased surveillance and medicine management for those at risk.

• An automated real-time electronic alert to ensure early detection that triggers an intervention bundle implemented by frontline staff who target any deteriorating patient.

• Rapid referral to and review by nephrology in patients who required renal inputs.

• The conveyance of verbal and written information about AKI to patients and their caregivers.

STOP-AKI was initially launched in the nephrology ward and then scaled up to become part of routine management for all patients admitted to the hospital.

The researchers found that from October 2013 through September 2015, AKI mortality rates fell from a baseline of 26% to 19%, which represented an overall reduction in mortality of 27%. At the same time, hospital length of stay fell by 13%, which amounted to a 2.7-day reduction in length of stay.

“Early identification and intervention are the key factors [in treating AKI],” Dr. Chandrasekar said. “Our study is proof for this, which has shown a significant drop in mortality and reduction in length of stay in hospitalized patients.

“We used a whole system approach with multiple interventions at different levels that dovetail with each other and [are] designed to empower health care professionals, including [the] most junior person to intervene effectively,” he added.

Dr. Chandrasekar and his associates are developing metrics to assess AKI progression and its predictors.

The researchers reported having no financial disclosures. The meeting was sponsored by the American Society of Nephrology.

dbrunk@frontlinemedcom.com

SAN DIEGO – Shorter sleep duration is prospectively and independently associated with a faster decline in renal function, according to results from a large observational study.

“We know that people with chronic kidney disease have a disrupted sleep pattern, particularly those on dialysis,” lead study author Dr. Ciaran Joseph McMullan said in an interview in advance of Kidney Week 2015.

“Disrupted sleep is actually one of the symptoms of end-stage renal disease,” Dr. McMullan noted, “but what hasn’t been studied as much is when the sleep disturbances occur in the progression from normal kidney function to chronic kidney disease and further on to end-stage renal disease. It’s unclear at what point those abnormal sleep patterns develop.”

Medical research in the past decade has demonstrated that disrupting people’s sleep can affect their metabolism in profound ways, explained Dr. McMullan of the renal division at Brigham and Women’s Hospital, Boston.

“You can take healthy people, reduce their sleep each night to around 5 hours, and they can develop characteristics of diabetes,” he said. “In the long term, we know that people who sleep less are at increased risk of developing hypertension, an increased risk of developing diabetes, and an increased mortality overall. Two of the most important risk factors for kidney disease are diabetes and hypertension.”

For the current study, Dr. McMullan and his associates prospectively evaluated 4,238 participants from the Nurses’ Health Study who had their renal function measured on at least two occasions and had their sleep function reported in a 24-hour period between 1989 and 2000.

Sleep duration was based on self-report and included four categories: 5 hours or fewer per night, 6 hours per night, 7-8 hours per night, and 9 or more hours per night. Rapid decline in renal function was defined as a decline of estimated glomerular filtration rate (eGFR) of 25% or more over the 11-year period.

The researchers found that, compared with sleeping 7-8 hours per night, the adjusted odds ratios for a rapid decline in renal function were 1.65 for sleeping 5 or fewer hours per night, 1.31 for sleeping 6 hours per night, and 0.78 for sleeping 9 or more hours per night.

At the same time, the adjusted annualized decline in eGFR was 1.2 mL/min per 1.73 m² per year among those sleeping 5 or fewer hours per night, 0.9 mL/ per 1.73 m² per year among those sleeping 6 hours per night, and 0.8 mL/ per 1.73 m² per year among those sleeping 7-8 hours per night, as well as those sleeping 9 or more hours per night (P = .02 for trend).

“This is the first time that we’ve studied people longitudinally to see how their kidney function changes over time based on how much they sleep per night,” Dr. McMullan said.

While he acknowledged that the study is limited by its observational design, the findings “lead us to consider if normal kidney function is disrupted by short sleep that may cause an irreversible decline in kidney function over time.

“I think we need to repeat this study using more accurate measurements of sleep, [such as] polysomnography to measure sleep duration and quality of sleep more accurately,” he said. “This would help us answer the question, ‘Why do these individual with short sleep duration have a more rapid decline of their kidney function?’ ”

Dr. McMullan added that “we also don’t know if lengthening sleep duration in individuals who have habitual sleep restriction is beneficial for their kidney function. This would be important to know before we can make any kind of clinical recommendation.”

The study was supported by a grant from the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. McMullan reported having no financial disclosures.

dbrunk@frontlinemedcom.com

SAN DIEGO – Shorter sleep duration is prospectively and independently associated with a faster decline in renal function, according to results from a large observational study.

“We know that people with chronic kidney disease have a disrupted sleep pattern, particularly those on dialysis,” lead study author Dr. Ciaran Joseph McMullan said in an interview in advance of Kidney Week 2015.

“Disrupted sleep is actually one of the symptoms of end-stage renal disease,” Dr. McMullan noted, “but what hasn’t been studied as much is when the sleep disturbances occur in the progression from normal kidney function to chronic kidney disease and further on to end-stage renal disease. It’s unclear at what point those abnormal sleep patterns develop.”

Medical research in the past decade has demonstrated that disrupting people’s sleep can affect their metabolism in profound ways, explained Dr. McMullan of the renal division at Brigham and Women’s Hospital, Boston.

“You can take healthy people, reduce their sleep each night to around 5 hours, and they can develop characteristics of diabetes,” he said. “In the long term, we know that people who sleep less are at increased risk of developing hypertension, an increased risk of developing diabetes, and an increased mortality overall. Two of the most important risk factors for kidney disease are diabetes and hypertension.”

For the current study, Dr. McMullan and his associates prospectively evaluated 4,238 participants from the Nurses’ Health Study who had their renal function measured on at least two occasions and had their sleep function reported in a 24-hour period between 1989 and 2000.

Sleep duration was based on self-report and included four categories: 5 hours or fewer per night, 6 hours per night, 7-8 hours per night, and 9 or more hours per night. Rapid decline in renal function was defined as a decline of estimated glomerular filtration rate (eGFR) of 25% or more over the 11-year period.

The researchers found that, compared with sleeping 7-8 hours per night, the adjusted odds ratios for a rapid decline in renal function were 1.65 for sleeping 5 or fewer hours per night, 1.31 for sleeping 6 hours per night, and 0.78 for sleeping 9 or more hours per night.

At the same time, the adjusted annualized decline in eGFR was 1.2 mL/min per 1.73 m² per year among those sleeping 5 or fewer hours per night, 0.9 mL/ per 1.73 m² per year among those sleeping 6 hours per night, and 0.8 mL/ per 1.73 m² per year among those sleeping 7-8 hours per night, as well as those sleeping 9 or more hours per night (P = .02 for trend).

“This is the first time that we’ve studied people longitudinally to see how their kidney function changes over time based on how much they sleep per night,” Dr. McMullan said.

While he acknowledged that the study is limited by its observational design, the findings “lead us to consider if normal kidney function is disrupted by short sleep that may cause an irreversible decline in kidney function over time.

“I think we need to repeat this study using more accurate measurements of sleep, [such as] polysomnography to measure sleep duration and quality of sleep more accurately,” he said. “This would help us answer the question, ‘Why do these individual with short sleep duration have a more rapid decline of their kidney function?’ ”

Dr. McMullan added that “we also don’t know if lengthening sleep duration in individuals who have habitual sleep restriction is beneficial for their kidney function. This would be important to know before we can make any kind of clinical recommendation.”

The study was supported by a grant from the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. McMullan reported having no financial disclosures.

dbrunk@frontlinemedcom.com

SAN DIEGO – Shorter sleep duration is prospectively and independently associated with a faster decline in renal function, according to results from a large observational study.

“We know that people with chronic kidney disease have a disrupted sleep pattern, particularly those on dialysis,” lead study author Dr. Ciaran Joseph McMullan said in an interview in advance of Kidney Week 2015.

“Disrupted sleep is actually one of the symptoms of end-stage renal disease,” Dr. McMullan noted, “but what hasn’t been studied as much is when the sleep disturbances occur in the progression from normal kidney function to chronic kidney disease and further on to end-stage renal disease. It’s unclear at what point those abnormal sleep patterns develop.”

Medical research in the past decade has demonstrated that disrupting people’s sleep can affect their metabolism in profound ways, explained Dr. McMullan of the renal division at Brigham and Women’s Hospital, Boston.

“You can take healthy people, reduce their sleep each night to around 5 hours, and they can develop characteristics of diabetes,” he said. “In the long term, we know that people who sleep less are at increased risk of developing hypertension, an increased risk of developing diabetes, and an increased mortality overall. Two of the most important risk factors for kidney disease are diabetes and hypertension.”

For the current study, Dr. McMullan and his associates prospectively evaluated 4,238 participants from the Nurses’ Health Study who had their renal function measured on at least two occasions and had their sleep function reported in a 24-hour period between 1989 and 2000.

Sleep duration was based on self-report and included four categories: 5 hours or fewer per night, 6 hours per night, 7-8 hours per night, and 9 or more hours per night. Rapid decline in renal function was defined as a decline of estimated glomerular filtration rate (eGFR) of 25% or more over the 11-year period.

The researchers found that, compared with sleeping 7-8 hours per night, the adjusted odds ratios for a rapid decline in renal function were 1.65 for sleeping 5 or fewer hours per night, 1.31 for sleeping 6 hours per night, and 0.78 for sleeping 9 or more hours per night.

At the same time, the adjusted annualized decline in eGFR was 1.2 mL/min per 1.73 m² per year among those sleeping 5 or fewer hours per night, 0.9 mL/ per 1.73 m² per year among those sleeping 6 hours per night, and 0.8 mL/ per 1.73 m² per year among those sleeping 7-8 hours per night, as well as those sleeping 9 or more hours per night (P = .02 for trend).

“This is the first time that we’ve studied people longitudinally to see how their kidney function changes over time based on how much they sleep per night,” Dr. McMullan said.

While he acknowledged that the study is limited by its observational design, the findings “lead us to consider if normal kidney function is disrupted by short sleep that may cause an irreversible decline in kidney function over time.

“I think we need to repeat this study using more accurate measurements of sleep, [such as] polysomnography to measure sleep duration and quality of sleep more accurately,” he said. “This would help us answer the question, ‘Why do these individual with short sleep duration have a more rapid decline of their kidney function?’ ”

Dr. McMullan added that “we also don’t know if lengthening sleep duration in individuals who have habitual sleep restriction is beneficial for their kidney function. This would be important to know before we can make any kind of clinical recommendation.”

The study was supported by a grant from the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. McMullan reported having no financial disclosures.

dbrunk@frontlinemedcom.com