Amy Karon

Patients with septic shock had similar outcomes when transfused at hemoglobin thresholds of 7 g/dL as compared with 9 g/dL, investigators reported online Oct. 1 in the New England Journal of Medicine.

Mortality at 90 days, use of life support, number of days alive and out of the hospital, number of ischemic events, and severe adverse reactions to blood in the intensive care unit (ICU) all were similar between the two groups, said Dr. Lars B. Holst at Rigshospitalet and the University of Copenhagen and his associates. At the same time, patients treated at the lower threshold received three times as many units of blood as did those treated at the higher threshold (median of 4 units and 1 unit, respectively), the researchers reported.

For the multicenter Transfusion Requirements in Septic Shock (TRISS) trial, the investigators randomized 998 ICU patients with septic shock to receive 1 unit of leukoreduced red cells when their hemoglobin level was either 9 g/dL or less (higher threshold) or 7 g/dL or less (lower threshold). Ninety days later, 43% of patients in the 7-g/dL threshold group had died, compared with 45% of the higher-threshold group, a nonsignificant difference, the investigators said. Controlling for baseline risk factors did not affect the finding, they reported (N. Engl. J. Med. 2014 Oct. 1 [doi: 10.1056/NEJMoa1406617]).

Rates of ischemic events and the need for life support also did not differ significantly between the two groups, Dr. Holst and his associates reported.

The study was funded by the Copenhagen University Hospital, Rigshospitalet, and several Scandinavian research foundations. Two coauthors reported financial relationships with Pharmacosmos, CSL Behring, and other companies. The other authors reported no conflicts of interest.

Patients with septic shock had similar outcomes when transfused at hemoglobin thresholds of 7 g/dL as compared with 9 g/dL, investigators reported online Oct. 1 in the New England Journal of Medicine.

Mortality at 90 days, use of life support, number of days alive and out of the hospital, number of ischemic events, and severe adverse reactions to blood in the intensive care unit (ICU) all were similar between the two groups, said Dr. Lars B. Holst at Rigshospitalet and the University of Copenhagen and his associates. At the same time, patients treated at the lower threshold received three times as many units of blood as did those treated at the higher threshold (median of 4 units and 1 unit, respectively), the researchers reported.

For the multicenter Transfusion Requirements in Septic Shock (TRISS) trial, the investigators randomized 998 ICU patients with septic shock to receive 1 unit of leukoreduced red cells when their hemoglobin level was either 9 g/dL or less (higher threshold) or 7 g/dL or less (lower threshold). Ninety days later, 43% of patients in the 7-g/dL threshold group had died, compared with 45% of the higher-threshold group, a nonsignificant difference, the investigators said. Controlling for baseline risk factors did not affect the finding, they reported (N. Engl. J. Med. 2014 Oct. 1 [doi: 10.1056/NEJMoa1406617]).

Rates of ischemic events and the need for life support also did not differ significantly between the two groups, Dr. Holst and his associates reported.

The study was funded by the Copenhagen University Hospital, Rigshospitalet, and several Scandinavian research foundations. Two coauthors reported financial relationships with Pharmacosmos, CSL Behring, and other companies. The other authors reported no conflicts of interest.

Patients with septic shock had similar outcomes when transfused at hemoglobin thresholds of 7 g/dL as compared with 9 g/dL, investigators reported online Oct. 1 in the New England Journal of Medicine.

Mortality at 90 days, use of life support, number of days alive and out of the hospital, number of ischemic events, and severe adverse reactions to blood in the intensive care unit (ICU) all were similar between the two groups, said Dr. Lars B. Holst at Rigshospitalet and the University of Copenhagen and his associates. At the same time, patients treated at the lower threshold received three times as many units of blood as did those treated at the higher threshold (median of 4 units and 1 unit, respectively), the researchers reported.

For the multicenter Transfusion Requirements in Septic Shock (TRISS) trial, the investigators randomized 998 ICU patients with septic shock to receive 1 unit of leukoreduced red cells when their hemoglobin level was either 9 g/dL or less (higher threshold) or 7 g/dL or less (lower threshold). Ninety days later, 43% of patients in the 7-g/dL threshold group had died, compared with 45% of the higher-threshold group, a nonsignificant difference, the investigators said. Controlling for baseline risk factors did not affect the finding, they reported (N. Engl. J. Med. 2014 Oct. 1 [doi: 10.1056/NEJMoa1406617]).

Rates of ischemic events and the need for life support also did not differ significantly between the two groups, Dr. Holst and his associates reported.

The study was funded by the Copenhagen University Hospital, Rigshospitalet, and several Scandinavian research foundations. Two coauthors reported financial relationships with Pharmacosmos, CSL Behring, and other companies. The other authors reported no conflicts of interest.

Combining nonsteroidal anti-inflammatory drugs with selective serotonin reuptake inhibitors increased the risk of upper gastrointestinal bleeding by up to 190% beyond the baseline risk found for NSAID monotherapy, researchers reported in the October issue of Gastroenterology.

Patients also faced excess risks of upper GI bleeding when they took corticosteroids, aldosterone antagonists, or anticoagulants together with low-dose aspirin or nonselective NSAIDs, although the effect was not seen for COX-2 inhibitors, said Dr. Gwen Masclee at Erasmus Medical Center in Rotterdam, the Netherlands and her associates.

Source: American Gastroenterological Association

The findings should help clinicians tailor treatments to minimize chances of upper gastrointestinal bleeding, particularly for elderly patients who often take multiple drugs, the investigators said (Gastroenterology 2014 [doi:10.1053/j.gastro.2014.06.007]).

The researchers analyzed 114,835 cases of upper gastrointestinal bleeding, including all gastroduodenal ulcers and hemorrhages extracted from seven electronic health record databases from the Netherlands, Italy, and Denmark. Three databases included primary care data, and four were administrative claims data, the investigators said. Cases served as their own controls, they noted.

Monotherapy with prescription nonselective NSAIDs increased the chances of an upper gastrointestinal bleed by 4.3 times, compared with not using any of the drugs studied (95% confidence interval, 4.1-4.4), the researchers said. Notably, bleeding risk from taking either nonselective NSAIDs or corticosteroids was the same, they said, adding that previous studies have yielded inconsistent findings on the topic. The incidence ratios for monotherapy with low-dose aspirin and COX-2 inhibitors were slightly lower at 3.1 (95% CI, 2.9-3.2) and 2.9 (95% CI, 2.7-3.2), respectively, they added.

Combining nonselective NSAIDs, COX-2 inhibitors, or low-dose aspirin with SSRIs led to excess risks of upper gastrointestinal bleeding of 1.6 (95% CI, 0.5-2.6), 1.9 (95% CI, 0.2-3.4), and 0.49 (–0.05-1.03), respectively, the researchers reported. "From a biological point of view, this interaction seems plausible because SSRIs decrease the serotonin level, resulting in impaired thrombocyte aggregation and an increased risk of bleeding in general," they said.

Corticosteroids combined with nonselective NSAIDs led to the greatest increases in bleeding risk, with an incidence ratio of 12.8 (95% CI, 11.1-14.7), compared with nonuse of any drug studied, and an excess risk of 5.5 (3.7-7.3), compared with NSAID use alone, said the researchers. Adding aldosterone antagonists to nonselective NSAIDs led to an excess risk of 4.46, compared with using nonselective NSAIDs alone, they reported (95% CI, 1.79-7.13).

Because the study did not capture over-the-counter NSAID prescriptions, it could have underestimated use of these drugs, the investigators said. Also, changes in health or NSAID use during the study could have created residual confounding, although sensitivity analyses did not reveal problems, they reported. They added that misclassification of some data could have led them to underestimate risks. "Finally, we did not take any carryover effect or dose of drug exposure into account, which potentially limits the generalizability concerning causality of the associations," they concluded.

Five authors reported employment or other financial support from Erasmus University Medical Center, AstraZeneca, Janssen, PHARMO Institute, and the European Medicines Agency. The other authors reported no relevant conflicts of interests.

Combining nonsteroidal anti-inflammatory drugs with selective serotonin reuptake inhibitors increased the risk of upper gastrointestinal bleeding by up to 190% beyond the baseline risk found for NSAID monotherapy, researchers reported in the October issue of Gastroenterology.

Patients also faced excess risks of upper GI bleeding when they took corticosteroids, aldosterone antagonists, or anticoagulants together with low-dose aspirin or nonselective NSAIDs, although the effect was not seen for COX-2 inhibitors, said Dr. Gwen Masclee at Erasmus Medical Center in Rotterdam, the Netherlands and her associates.

Source: American Gastroenterological Association

The findings should help clinicians tailor treatments to minimize chances of upper gastrointestinal bleeding, particularly for elderly patients who often take multiple drugs, the investigators said (Gastroenterology 2014 [doi:10.1053/j.gastro.2014.06.007]).

The researchers analyzed 114,835 cases of upper gastrointestinal bleeding, including all gastroduodenal ulcers and hemorrhages extracted from seven electronic health record databases from the Netherlands, Italy, and Denmark. Three databases included primary care data, and four were administrative claims data, the investigators said. Cases served as their own controls, they noted.

Monotherapy with prescription nonselective NSAIDs increased the chances of an upper gastrointestinal bleed by 4.3 times, compared with not using any of the drugs studied (95% confidence interval, 4.1-4.4), the researchers said. Notably, bleeding risk from taking either nonselective NSAIDs or corticosteroids was the same, they said, adding that previous studies have yielded inconsistent findings on the topic. The incidence ratios for monotherapy with low-dose aspirin and COX-2 inhibitors were slightly lower at 3.1 (95% CI, 2.9-3.2) and 2.9 (95% CI, 2.7-3.2), respectively, they added.

Combining nonselective NSAIDs, COX-2 inhibitors, or low-dose aspirin with SSRIs led to excess risks of upper gastrointestinal bleeding of 1.6 (95% CI, 0.5-2.6), 1.9 (95% CI, 0.2-3.4), and 0.49 (–0.05-1.03), respectively, the researchers reported. "From a biological point of view, this interaction seems plausible because SSRIs decrease the serotonin level, resulting in impaired thrombocyte aggregation and an increased risk of bleeding in general," they said.

Corticosteroids combined with nonselective NSAIDs led to the greatest increases in bleeding risk, with an incidence ratio of 12.8 (95% CI, 11.1-14.7), compared with nonuse of any drug studied, and an excess risk of 5.5 (3.7-7.3), compared with NSAID use alone, said the researchers. Adding aldosterone antagonists to nonselective NSAIDs led to an excess risk of 4.46, compared with using nonselective NSAIDs alone, they reported (95% CI, 1.79-7.13).

Because the study did not capture over-the-counter NSAID prescriptions, it could have underestimated use of these drugs, the investigators said. Also, changes in health or NSAID use during the study could have created residual confounding, although sensitivity analyses did not reveal problems, they reported. They added that misclassification of some data could have led them to underestimate risks. "Finally, we did not take any carryover effect or dose of drug exposure into account, which potentially limits the generalizability concerning causality of the associations," they concluded.

Five authors reported employment or other financial support from Erasmus University Medical Center, AstraZeneca, Janssen, PHARMO Institute, and the European Medicines Agency. The other authors reported no relevant conflicts of interests.

Combining nonsteroidal anti-inflammatory drugs with selective serotonin reuptake inhibitors increased the risk of upper gastrointestinal bleeding by up to 190% beyond the baseline risk found for NSAID monotherapy, researchers reported in the October issue of Gastroenterology.

Patients also faced excess risks of upper GI bleeding when they took corticosteroids, aldosterone antagonists, or anticoagulants together with low-dose aspirin or nonselective NSAIDs, although the effect was not seen for COX-2 inhibitors, said Dr. Gwen Masclee at Erasmus Medical Center in Rotterdam, the Netherlands and her associates.

Source: American Gastroenterological Association

The findings should help clinicians tailor treatments to minimize chances of upper gastrointestinal bleeding, particularly for elderly patients who often take multiple drugs, the investigators said (Gastroenterology 2014 [doi:10.1053/j.gastro.2014.06.007]).

The researchers analyzed 114,835 cases of upper gastrointestinal bleeding, including all gastroduodenal ulcers and hemorrhages extracted from seven electronic health record databases from the Netherlands, Italy, and Denmark. Three databases included primary care data, and four were administrative claims data, the investigators said. Cases served as their own controls, they noted.

Monotherapy with prescription nonselective NSAIDs increased the chances of an upper gastrointestinal bleed by 4.3 times, compared with not using any of the drugs studied (95% confidence interval, 4.1-4.4), the researchers said. Notably, bleeding risk from taking either nonselective NSAIDs or corticosteroids was the same, they said, adding that previous studies have yielded inconsistent findings on the topic. The incidence ratios for monotherapy with low-dose aspirin and COX-2 inhibitors were slightly lower at 3.1 (95% CI, 2.9-3.2) and 2.9 (95% CI, 2.7-3.2), respectively, they added.

Combining nonselective NSAIDs, COX-2 inhibitors, or low-dose aspirin with SSRIs led to excess risks of upper gastrointestinal bleeding of 1.6 (95% CI, 0.5-2.6), 1.9 (95% CI, 0.2-3.4), and 0.49 (–0.05-1.03), respectively, the researchers reported. "From a biological point of view, this interaction seems plausible because SSRIs decrease the serotonin level, resulting in impaired thrombocyte aggregation and an increased risk of bleeding in general," they said.

Corticosteroids combined with nonselective NSAIDs led to the greatest increases in bleeding risk, with an incidence ratio of 12.8 (95% CI, 11.1-14.7), compared with nonuse of any drug studied, and an excess risk of 5.5 (3.7-7.3), compared with NSAID use alone, said the researchers. Adding aldosterone antagonists to nonselective NSAIDs led to an excess risk of 4.46, compared with using nonselective NSAIDs alone, they reported (95% CI, 1.79-7.13).

Because the study did not capture over-the-counter NSAID prescriptions, it could have underestimated use of these drugs, the investigators said. Also, changes in health or NSAID use during the study could have created residual confounding, although sensitivity analyses did not reveal problems, they reported. They added that misclassification of some data could have led them to underestimate risks. "Finally, we did not take any carryover effect or dose of drug exposure into account, which potentially limits the generalizability concerning causality of the associations," they concluded.

Five authors reported employment or other financial support from Erasmus University Medical Center, AstraZeneca, Janssen, PHARMO Institute, and the European Medicines Agency. The other authors reported no relevant conflicts of interests.

A risk stratification model that determined whether patients with Crohn’s disease needed computed tomography cut scans of these patients in emergency departments by 43%, with a miss rate of only 0.8%, researchers reported online in Clinical Gastroenterology and Hepatology.

Computed tomography scans yield nonsignificant findings for almost one-third of patients with Crohn’s disease (CD) who present to emergency departments, said Dr. Shail Govani of the University of Michigan in Ann Arbor and his associates. By using their model to identify patients with serious gastrointestinal complications as opposed to straightforward intestinal inflammation, emergency departments could prevent more than 250 cancer cases and save more than $80 million per decade in the United States, the investigators added.

Source: American Gastroenterological Association

Patients with CD may be exposed to increasing cumulative radiation levels, and 30% of this exposure occurs in emergency departments, with 75% due to CT scans, the researchers said (Clin. Gastroenterol. Hepatol. 2014 [doi:10.1016/j.cgh.2014.02.036]).

For the study, the investigators retrospectively reviewed electronic medical records from the University of Michigan from 2000 through 2011, identifying 613 adults with CD who made 1,095 visits that included CT scans within 24 hours of presentation. The researchers then modeled associations between laboratory values and perforation, abscess, or other serious complications as opposed to intestinal inflammation.

Patients averaged 1.8 CT scans during the decade-long study period, and the overall rate of CT scans during that time rose from 63% to 87%, the investigators said. Only 16.8% of scans revealed a complication that would change clinical management, they reported.

Only C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR) were significantly associated with complications (odds ratio for CRP, 1.10; 95% confidence interval, 1.05-1.15; P less than .001; odds ratio for ESR, 1.02; 95% CI, 1.01-1.03; P less than .001), the researchers said. Adding ESR to 5 x CRP and not scanning patients with a resulting value of 10 or less would avoid CT scans in 18.5% of patients, they reported. But by using the more complex logistic regression model instead of the simpler equation, scans could be avoided for 43.0% of patients, with a miss rate of 0.8%, they said.

Based on the study, patients assessed as likely to have complications should undergo a standard CT scan of the abdomen and pelvis with nonbarium contrast to avoid barium peritonitis, said Dr. Govani and associates. Other patients should forego CT scans, have a consult with a gastroenterologist prior to further imaging, or undergo lower-radiation CT enterography, depending on presenting signs and probability of inflammation, they added.

The researchers said they were unable to construct good models that included obstruction as an outcome. Patients with suspected obstructions should have abdominal x-rays and then CT if an obstruction remained likely, they said.

"These models are limited in that they are retrospective and represent data from one center," the investigators added. "Although our internal validation with 10-fold cross-validation shows that these models have good performance characteristics, further external validation studies are needed to determine whether these models are generalizable to CD patients elsewhere."

The authors are prospectively testing the algorithms and hope to continue to validate and study them in emergency departments, they said.

The Inflammatory Bowel Disease Working Group, the Department of Veterans Affairs, and UCB supported the research. The authors reported having no conflicts of interest.

A risk stratification model that determined whether patients with Crohn’s disease needed computed tomography cut scans of these patients in emergency departments by 43%, with a miss rate of only 0.8%, researchers reported online in Clinical Gastroenterology and Hepatology.

Computed tomography scans yield nonsignificant findings for almost one-third of patients with Crohn’s disease (CD) who present to emergency departments, said Dr. Shail Govani of the University of Michigan in Ann Arbor and his associates. By using their model to identify patients with serious gastrointestinal complications as opposed to straightforward intestinal inflammation, emergency departments could prevent more than 250 cancer cases and save more than $80 million per decade in the United States, the investigators added.

Source: American Gastroenterological Association

Patients with CD may be exposed to increasing cumulative radiation levels, and 30% of this exposure occurs in emergency departments, with 75% due to CT scans, the researchers said (Clin. Gastroenterol. Hepatol. 2014 [doi:10.1016/j.cgh.2014.02.036]).

For the study, the investigators retrospectively reviewed electronic medical records from the University of Michigan from 2000 through 2011, identifying 613 adults with CD who made 1,095 visits that included CT scans within 24 hours of presentation. The researchers then modeled associations between laboratory values and perforation, abscess, or other serious complications as opposed to intestinal inflammation.

Patients averaged 1.8 CT scans during the decade-long study period, and the overall rate of CT scans during that time rose from 63% to 87%, the investigators said. Only 16.8% of scans revealed a complication that would change clinical management, they reported.

Only C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR) were significantly associated with complications (odds ratio for CRP, 1.10; 95% confidence interval, 1.05-1.15; P less than .001; odds ratio for ESR, 1.02; 95% CI, 1.01-1.03; P less than .001), the researchers said. Adding ESR to 5 x CRP and not scanning patients with a resulting value of 10 or less would avoid CT scans in 18.5% of patients, they reported. But by using the more complex logistic regression model instead of the simpler equation, scans could be avoided for 43.0% of patients, with a miss rate of 0.8%, they said.

Based on the study, patients assessed as likely to have complications should undergo a standard CT scan of the abdomen and pelvis with nonbarium contrast to avoid barium peritonitis, said Dr. Govani and associates. Other patients should forego CT scans, have a consult with a gastroenterologist prior to further imaging, or undergo lower-radiation CT enterography, depending on presenting signs and probability of inflammation, they added.

The researchers said they were unable to construct good models that included obstruction as an outcome. Patients with suspected obstructions should have abdominal x-rays and then CT if an obstruction remained likely, they said.

"These models are limited in that they are retrospective and represent data from one center," the investigators added. "Although our internal validation with 10-fold cross-validation shows that these models have good performance characteristics, further external validation studies are needed to determine whether these models are generalizable to CD patients elsewhere."

The authors are prospectively testing the algorithms and hope to continue to validate and study them in emergency departments, they said.

The Inflammatory Bowel Disease Working Group, the Department of Veterans Affairs, and UCB supported the research. The authors reported having no conflicts of interest.

A risk stratification model that determined whether patients with Crohn’s disease needed computed tomography cut scans of these patients in emergency departments by 43%, with a miss rate of only 0.8%, researchers reported online in Clinical Gastroenterology and Hepatology.

Computed tomography scans yield nonsignificant findings for almost one-third of patients with Crohn’s disease (CD) who present to emergency departments, said Dr. Shail Govani of the University of Michigan in Ann Arbor and his associates. By using their model to identify patients with serious gastrointestinal complications as opposed to straightforward intestinal inflammation, emergency departments could prevent more than 250 cancer cases and save more than $80 million per decade in the United States, the investigators added.

Source: American Gastroenterological Association

Patients with CD may be exposed to increasing cumulative radiation levels, and 30% of this exposure occurs in emergency departments, with 75% due to CT scans, the researchers said (Clin. Gastroenterol. Hepatol. 2014 [doi:10.1016/j.cgh.2014.02.036]).

For the study, the investigators retrospectively reviewed electronic medical records from the University of Michigan from 2000 through 2011, identifying 613 adults with CD who made 1,095 visits that included CT scans within 24 hours of presentation. The researchers then modeled associations between laboratory values and perforation, abscess, or other serious complications as opposed to intestinal inflammation.

Patients averaged 1.8 CT scans during the decade-long study period, and the overall rate of CT scans during that time rose from 63% to 87%, the investigators said. Only 16.8% of scans revealed a complication that would change clinical management, they reported.

Only C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR) were significantly associated with complications (odds ratio for CRP, 1.10; 95% confidence interval, 1.05-1.15; P less than .001; odds ratio for ESR, 1.02; 95% CI, 1.01-1.03; P less than .001), the researchers said. Adding ESR to 5 x CRP and not scanning patients with a resulting value of 10 or less would avoid CT scans in 18.5% of patients, they reported. But by using the more complex logistic regression model instead of the simpler equation, scans could be avoided for 43.0% of patients, with a miss rate of 0.8%, they said.

Based on the study, patients assessed as likely to have complications should undergo a standard CT scan of the abdomen and pelvis with nonbarium contrast to avoid barium peritonitis, said Dr. Govani and associates. Other patients should forego CT scans, have a consult with a gastroenterologist prior to further imaging, or undergo lower-radiation CT enterography, depending on presenting signs and probability of inflammation, they added.

The researchers said they were unable to construct good models that included obstruction as an outcome. Patients with suspected obstructions should have abdominal x-rays and then CT if an obstruction remained likely, they said.

"These models are limited in that they are retrospective and represent data from one center," the investigators added. "Although our internal validation with 10-fold cross-validation shows that these models have good performance characteristics, further external validation studies are needed to determine whether these models are generalizable to CD patients elsewhere."

The authors are prospectively testing the algorithms and hope to continue to validate and study them in emergency departments, they said.

The Inflammatory Bowel Disease Working Group, the Department of Veterans Affairs, and UCB supported the research. The authors reported having no conflicts of interest.

Cytology and a microRNA-based test identified pancreatic cancer 91% of the time in specimens obtained by endoscopic ultrasound-guided fine-needle aspiration – a substantial improvement, compared with cytology alone, researchers reported in the October issue of Clinical Gastroenterology and Hepatology.

The microRNA-based test could help reduce repeated fine-needle aspirations (FNAs) due to indeterminate cytologies, said Dr. Randall Brand of the University of Pittsburgh Medical Center and his associates. Correctly assessing pancreatic cancer before surgery also could help patients start neoadjuvant therapy sooner if appropriate, they noted.

© goa_novi / ThinkStockPhotos.com

Several microRNAs are expressed abnormally in patients with pancreatic ductal adenocarcinoma. The new test contains five of these sequences and is the first of its type for pancreatic cancer, the researchers said. To evaluate the assay, they assessed and compared relative quantitative polymerase chain reaction and cytology results from 95 formalin-fixed paraffin-embedded specimens and 228 endoscopic ultrasound-guided FNAs. Specimens were collected during routine visits by patients with solid pancreatic masses, the investigators said (Clin. Gastroenterol. Hepatol. 2014 October [doi:10.1016/j.cgh.2014.02.038]).

The test used together with cytology correctly identified pancreatic cancer in 91% of positive specimens (95% confidence interval, 85.6%-94.5%), while cytology alone had a sensitivity of 79% (95% CI, 72.2%-84.5%), the researchers reported. Cytology and the microRNA test each had positive predictive values greater than 99% (95% CI, 96%-100%), they added.

When used alone, the microRNA test had a diagnostic sensitivity of more than 82% and a specificity of 96% – better than cytology on the same specimens, the investigators said. And the test correctly found pancreatic cancer in 22 of 39 specimens previously assessed as benign, indeterminate, or nondiagnostic by cytology, they said.

The researchers separately assessed 46 specimens collected percutaneously instead of by endoscopic ultrasound-guided FNA and found much lower (58%) diagnostic sensitivity and a higher rate of technical failures, although specificity and predictive value still approached 90%, said the investigators. The percutaneous specimens all were collected from two study sites outside the United States, so further studies would need to validate whether a percutaneous approach could replace endoscopic ultrasound-guided FNA, they said.

Cytology and microRNA testing also had to be performed on different FNA specimens, a limitation that "could have contributed to some of the observed discrepancies between cytology and molecular results," the investigators said.

Pancreatic cancer remains notoriously difficult to treat, with overall 5-year survival rates of only about 6%. MicroRNA sequences are stable and can reliably be recovered from both formalin-fixed and FNA specimens, making them a "particularly promising" class of biomarkers for pancreatic and other cancers, the researchers said. Based on the study results, future studies should explore the test’s prognostic potential, such as for distinguishing patients with resectable tumors that are likely to progress early or to guide choice of therapies, they said.

The study was supported by Asuragen and by a grant from the German Federal Ministry of Education and Research. Dr. Brand and another author reported that they are on the clinical advisory board of Asuragen, and six of 27 coauthors reported being employees of the company. The rest reported no conflicts of interest.

Cytology and a microRNA-based test identified pancreatic cancer 91% of the time in specimens obtained by endoscopic ultrasound-guided fine-needle aspiration – a substantial improvement, compared with cytology alone, researchers reported in the October issue of Clinical Gastroenterology and Hepatology.

The microRNA-based test could help reduce repeated fine-needle aspirations (FNAs) due to indeterminate cytologies, said Dr. Randall Brand of the University of Pittsburgh Medical Center and his associates. Correctly assessing pancreatic cancer before surgery also could help patients start neoadjuvant therapy sooner if appropriate, they noted.

© goa_novi / ThinkStockPhotos.com

Several microRNAs are expressed abnormally in patients with pancreatic ductal adenocarcinoma. The new test contains five of these sequences and is the first of its type for pancreatic cancer, the researchers said. To evaluate the assay, they assessed and compared relative quantitative polymerase chain reaction and cytology results from 95 formalin-fixed paraffin-embedded specimens and 228 endoscopic ultrasound-guided FNAs. Specimens were collected during routine visits by patients with solid pancreatic masses, the investigators said (Clin. Gastroenterol. Hepatol. 2014 October [doi:10.1016/j.cgh.2014.02.038]).

The test used together with cytology correctly identified pancreatic cancer in 91% of positive specimens (95% confidence interval, 85.6%-94.5%), while cytology alone had a sensitivity of 79% (95% CI, 72.2%-84.5%), the researchers reported. Cytology and the microRNA test each had positive predictive values greater than 99% (95% CI, 96%-100%), they added.

When used alone, the microRNA test had a diagnostic sensitivity of more than 82% and a specificity of 96% – better than cytology on the same specimens, the investigators said. And the test correctly found pancreatic cancer in 22 of 39 specimens previously assessed as benign, indeterminate, or nondiagnostic by cytology, they said.

The researchers separately assessed 46 specimens collected percutaneously instead of by endoscopic ultrasound-guided FNA and found much lower (58%) diagnostic sensitivity and a higher rate of technical failures, although specificity and predictive value still approached 90%, said the investigators. The percutaneous specimens all were collected from two study sites outside the United States, so further studies would need to validate whether a percutaneous approach could replace endoscopic ultrasound-guided FNA, they said.

Cytology and microRNA testing also had to be performed on different FNA specimens, a limitation that "could have contributed to some of the observed discrepancies between cytology and molecular results," the investigators said.

Pancreatic cancer remains notoriously difficult to treat, with overall 5-year survival rates of only about 6%. MicroRNA sequences are stable and can reliably be recovered from both formalin-fixed and FNA specimens, making them a "particularly promising" class of biomarkers for pancreatic and other cancers, the researchers said. Based on the study results, future studies should explore the test’s prognostic potential, such as for distinguishing patients with resectable tumors that are likely to progress early or to guide choice of therapies, they said.

The study was supported by Asuragen and by a grant from the German Federal Ministry of Education and Research. Dr. Brand and another author reported that they are on the clinical advisory board of Asuragen, and six of 27 coauthors reported being employees of the company. The rest reported no conflicts of interest.

Cytology and a microRNA-based test identified pancreatic cancer 91% of the time in specimens obtained by endoscopic ultrasound-guided fine-needle aspiration – a substantial improvement, compared with cytology alone, researchers reported in the October issue of Clinical Gastroenterology and Hepatology.

The microRNA-based test could help reduce repeated fine-needle aspirations (FNAs) due to indeterminate cytologies, said Dr. Randall Brand of the University of Pittsburgh Medical Center and his associates. Correctly assessing pancreatic cancer before surgery also could help patients start neoadjuvant therapy sooner if appropriate, they noted.

© goa_novi / ThinkStockPhotos.com

Several microRNAs are expressed abnormally in patients with pancreatic ductal adenocarcinoma. The new test contains five of these sequences and is the first of its type for pancreatic cancer, the researchers said. To evaluate the assay, they assessed and compared relative quantitative polymerase chain reaction and cytology results from 95 formalin-fixed paraffin-embedded specimens and 228 endoscopic ultrasound-guided FNAs. Specimens were collected during routine visits by patients with solid pancreatic masses, the investigators said (Clin. Gastroenterol. Hepatol. 2014 October [doi:10.1016/j.cgh.2014.02.038]).

The test used together with cytology correctly identified pancreatic cancer in 91% of positive specimens (95% confidence interval, 85.6%-94.5%), while cytology alone had a sensitivity of 79% (95% CI, 72.2%-84.5%), the researchers reported. Cytology and the microRNA test each had positive predictive values greater than 99% (95% CI, 96%-100%), they added.

When used alone, the microRNA test had a diagnostic sensitivity of more than 82% and a specificity of 96% – better than cytology on the same specimens, the investigators said. And the test correctly found pancreatic cancer in 22 of 39 specimens previously assessed as benign, indeterminate, or nondiagnostic by cytology, they said.

The researchers separately assessed 46 specimens collected percutaneously instead of by endoscopic ultrasound-guided FNA and found much lower (58%) diagnostic sensitivity and a higher rate of technical failures, although specificity and predictive value still approached 90%, said the investigators. The percutaneous specimens all were collected from two study sites outside the United States, so further studies would need to validate whether a percutaneous approach could replace endoscopic ultrasound-guided FNA, they said.

Cytology and microRNA testing also had to be performed on different FNA specimens, a limitation that "could have contributed to some of the observed discrepancies between cytology and molecular results," the investigators said.

Pancreatic cancer remains notoriously difficult to treat, with overall 5-year survival rates of only about 6%. MicroRNA sequences are stable and can reliably be recovered from both formalin-fixed and FNA specimens, making them a "particularly promising" class of biomarkers for pancreatic and other cancers, the researchers said. Based on the study results, future studies should explore the test’s prognostic potential, such as for distinguishing patients with resectable tumors that are likely to progress early or to guide choice of therapies, they said.

The study was supported by Asuragen and by a grant from the German Federal Ministry of Education and Research. Dr. Brand and another author reported that they are on the clinical advisory board of Asuragen, and six of 27 coauthors reported being employees of the company. The rest reported no conflicts of interest.

Simvastatin did not improve clinical outcomes in adults with respiratory distress syndrome, compared with placebo, according to investigators.

The report was published online Sept. 30 in the New England Journal of Medicine.

Despite positive findings in early-phase studies, large clinical trials have failed to show that statins benefit patients with ARDS, said Dr. Daniel McAuley of Queen’s University of Belfast, Ireland, and his associates. The earlier studies used surrogate measures that do not clearly correlate with patient-specific outcomes, the researchers said. “Surrogate outcomes that more closely track patient outcomes need to be identified,” they added (N. Engl. J. Med. 2014 Sept. 30 [doi: 10.1056/NEJMoa1403285]).

The multicenter, double-blind trial comprised 540 adults with ARDS from 40 intensive care units in the United Kingdom and Ireland. Patients were randomized to enteral simvastatin or placebo, and the groups did not differ significantly in terms of number of ventilator-free days (12.6 vs. 11.5 days, respectively), days free of nonpulmonary organ failure (19.4 vs. 17.8 days), or 28-day mortality (22% vs. 26.8%), the investigators reported. Adverse effects also were similar between the groups, they said.

The researchers recruited a heterogeneous cohort of patients with ARDS resulting from any cause so that findings would be generalizable, they wrote. Because recent research suggests that identification of specific phenotypes within ARDS may be possible, future studies “may identify a subpopulation of patients with ARDS who might have a greater response to simvastatin than was observed in our study,” they noted.

The study was funded by the U.K. Efficacy and Mechanism Evaluation Programme, a joint partnership of the Medical Research Council and the National Institute for Health Research. Dr. McAuley reported financial ties to GlaxoSmithKline as well as a patent pending application related to a novel treatment for ARDS.

Simvastatin did not improve clinical outcomes in adults with respiratory distress syndrome, compared with placebo, according to investigators.

The report was published online Sept. 30 in the New England Journal of Medicine.

Despite positive findings in early-phase studies, large clinical trials have failed to show that statins benefit patients with ARDS, said Dr. Daniel McAuley of Queen’s University of Belfast, Ireland, and his associates. The earlier studies used surrogate measures that do not clearly correlate with patient-specific outcomes, the researchers said. “Surrogate outcomes that more closely track patient outcomes need to be identified,” they added (N. Engl. J. Med. 2014 Sept. 30 [doi: 10.1056/NEJMoa1403285]).

The multicenter, double-blind trial comprised 540 adults with ARDS from 40 intensive care units in the United Kingdom and Ireland. Patients were randomized to enteral simvastatin or placebo, and the groups did not differ significantly in terms of number of ventilator-free days (12.6 vs. 11.5 days, respectively), days free of nonpulmonary organ failure (19.4 vs. 17.8 days), or 28-day mortality (22% vs. 26.8%), the investigators reported. Adverse effects also were similar between the groups, they said.

The researchers recruited a heterogeneous cohort of patients with ARDS resulting from any cause so that findings would be generalizable, they wrote. Because recent research suggests that identification of specific phenotypes within ARDS may be possible, future studies “may identify a subpopulation of patients with ARDS who might have a greater response to simvastatin than was observed in our study,” they noted.

The study was funded by the U.K. Efficacy and Mechanism Evaluation Programme, a joint partnership of the Medical Research Council and the National Institute for Health Research. Dr. McAuley reported financial ties to GlaxoSmithKline as well as a patent pending application related to a novel treatment for ARDS.

Simvastatin did not improve clinical outcomes in adults with respiratory distress syndrome, compared with placebo, according to investigators.

The report was published online Sept. 30 in the New England Journal of Medicine.

Despite positive findings in early-phase studies, large clinical trials have failed to show that statins benefit patients with ARDS, said Dr. Daniel McAuley of Queen’s University of Belfast, Ireland, and his associates. The earlier studies used surrogate measures that do not clearly correlate with patient-specific outcomes, the researchers said. “Surrogate outcomes that more closely track patient outcomes need to be identified,” they added (N. Engl. J. Med. 2014 Sept. 30 [doi: 10.1056/NEJMoa1403285]).

The multicenter, double-blind trial comprised 540 adults with ARDS from 40 intensive care units in the United Kingdom and Ireland. Patients were randomized to enteral simvastatin or placebo, and the groups did not differ significantly in terms of number of ventilator-free days (12.6 vs. 11.5 days, respectively), days free of nonpulmonary organ failure (19.4 vs. 17.8 days), or 28-day mortality (22% vs. 26.8%), the investigators reported. Adverse effects also were similar between the groups, they said.

The researchers recruited a heterogeneous cohort of patients with ARDS resulting from any cause so that findings would be generalizable, they wrote. Because recent research suggests that identification of specific phenotypes within ARDS may be possible, future studies “may identify a subpopulation of patients with ARDS who might have a greater response to simvastatin than was observed in our study,” they noted.

The study was funded by the U.K. Efficacy and Mechanism Evaluation Programme, a joint partnership of the Medical Research Council and the National Institute for Health Research. Dr. McAuley reported financial ties to GlaxoSmithKline as well as a patent pending application related to a novel treatment for ARDS.

High-dose vitamin D did not improve outcomes in critically ill, vitamin D­–deficient patients, compared with placebo, researchers reported in JAMA and at the annual congress of the European Society of Intensive Care Medicine.

©Joss/Fotolia.com

Although the study was adequately powered, length of stay did not differ between the vitamin D and placebo groups, said Dr. Karin Amrein of the Medical University of Graz, Austria, and her associates. “In the overall cohort, hospital and 6-month mortality rates were numerically lower in the vitamin D3 group, but these differences were not significant,” the researchers said.

A subgroup of patients with severe vitamin D deficiency did have significantly lower hospital mortality when treated with vitamin D, compared with placebo, but the effect “should be considered hypothesis generating and requires further study,” the investigators concluded (JAMA 2014 Sept. 29 [doi:10.1001/jama.2014.13204]).

The randomized, double-blind, single-center trial enrolled 492 critically ill medical and surgical patients with serum vitamin D levels of 20 ng/mL or less. Patients received placebo or vitamin D₃ at a loading dose of 540,000 IU, followed by a monthly maintenance dose of 90,000 IU for 5 months, the researchers said.

Length of hospital stay averaged 20.1 days for patients who received vitamin D and 19.3 days for the placebo group, the investigators reported.

Among patients who received vitamin D3, 28.3% died in the hospital, compared with 35.3% of the placebo group (hazard ratio, 0.81; 95% confidence interval, 0.58 to 1.11), they said. Six-month mortality was 35.0% for the vitamin D3 group, compared with 42.9% for the placebo group (HR, 0.78; 95% CI, 0.58-1.04), they said.

Among 200 patients with severe vitamin D deficiencies of 12 ng/mL or less, vitamin D₃ treatment was linked to a 44% drop in risk of dying in the hospital, the researchers said (28.6% vs. 46.1% for placebo; HR, 0.56; 95% CI, 0.35 to 0.90; P = .04).But length of hospital stay and 6-month mortality rates were similar between the two groups, they reported.

Drug maker Fresenius Kabi provided study medication and a grant to support the research. The European Society for Clinical Nutrition and Metabolism and the Austrian National Bank also funded the study.

Dr Amrein reported and one coauthor reported receiving lecture fees from Fresenius Kabi. The authors reported no other relevant financial conflicts of interest.

High-dose vitamin D did not improve outcomes in critically ill, vitamin D­–deficient patients, compared with placebo, researchers reported in JAMA and at the annual congress of the European Society of Intensive Care Medicine.

©Joss/Fotolia.com

Although the study was adequately powered, length of stay did not differ between the vitamin D and placebo groups, said Dr. Karin Amrein of the Medical University of Graz, Austria, and her associates. “In the overall cohort, hospital and 6-month mortality rates were numerically lower in the vitamin D3 group, but these differences were not significant,” the researchers said.

A subgroup of patients with severe vitamin D deficiency did have significantly lower hospital mortality when treated with vitamin D, compared with placebo, but the effect “should be considered hypothesis generating and requires further study,” the investigators concluded (JAMA 2014 Sept. 29 [doi:10.1001/jama.2014.13204]).

The randomized, double-blind, single-center trial enrolled 492 critically ill medical and surgical patients with serum vitamin D levels of 20 ng/mL or less. Patients received placebo or vitamin D₃ at a loading dose of 540,000 IU, followed by a monthly maintenance dose of 90,000 IU for 5 months, the researchers said.

Length of hospital stay averaged 20.1 days for patients who received vitamin D and 19.3 days for the placebo group, the investigators reported.

Among patients who received vitamin D3, 28.3% died in the hospital, compared with 35.3% of the placebo group (hazard ratio, 0.81; 95% confidence interval, 0.58 to 1.11), they said. Six-month mortality was 35.0% for the vitamin D3 group, compared with 42.9% for the placebo group (HR, 0.78; 95% CI, 0.58-1.04), they said.

Among 200 patients with severe vitamin D deficiencies of 12 ng/mL or less, vitamin D₃ treatment was linked to a 44% drop in risk of dying in the hospital, the researchers said (28.6% vs. 46.1% for placebo; HR, 0.56; 95% CI, 0.35 to 0.90; P = .04).But length of hospital stay and 6-month mortality rates were similar between the two groups, they reported.

Drug maker Fresenius Kabi provided study medication and a grant to support the research. The European Society for Clinical Nutrition and Metabolism and the Austrian National Bank also funded the study.

Dr Amrein reported and one coauthor reported receiving lecture fees from Fresenius Kabi. The authors reported no other relevant financial conflicts of interest.

High-dose vitamin D did not improve outcomes in critically ill, vitamin D­–deficient patients, compared with placebo, researchers reported in JAMA and at the annual congress of the European Society of Intensive Care Medicine.

©Joss/Fotolia.com

Although the study was adequately powered, length of stay did not differ between the vitamin D and placebo groups, said Dr. Karin Amrein of the Medical University of Graz, Austria, and her associates. “In the overall cohort, hospital and 6-month mortality rates were numerically lower in the vitamin D3 group, but these differences were not significant,” the researchers said.

A subgroup of patients with severe vitamin D deficiency did have significantly lower hospital mortality when treated with vitamin D, compared with placebo, but the effect “should be considered hypothesis generating and requires further study,” the investigators concluded (JAMA 2014 Sept. 29 [doi:10.1001/jama.2014.13204]).

The randomized, double-blind, single-center trial enrolled 492 critically ill medical and surgical patients with serum vitamin D levels of 20 ng/mL or less. Patients received placebo or vitamin D₃ at a loading dose of 540,000 IU, followed by a monthly maintenance dose of 90,000 IU for 5 months, the researchers said.

Length of hospital stay averaged 20.1 days for patients who received vitamin D and 19.3 days for the placebo group, the investigators reported.

Among patients who received vitamin D3, 28.3% died in the hospital, compared with 35.3% of the placebo group (hazard ratio, 0.81; 95% confidence interval, 0.58 to 1.11), they said. Six-month mortality was 35.0% for the vitamin D3 group, compared with 42.9% for the placebo group (HR, 0.78; 95% CI, 0.58-1.04), they said.

Among 200 patients with severe vitamin D deficiencies of 12 ng/mL or less, vitamin D₃ treatment was linked to a 44% drop in risk of dying in the hospital, the researchers said (28.6% vs. 46.1% for placebo; HR, 0.56; 95% CI, 0.35 to 0.90; P = .04).But length of hospital stay and 6-month mortality rates were similar between the two groups, they reported.

Drug maker Fresenius Kabi provided study medication and a grant to support the research. The European Society for Clinical Nutrition and Metabolism and the Austrian National Bank also funded the study.

Dr Amrein reported and one coauthor reported receiving lecture fees from Fresenius Kabi. The authors reported no other relevant financial conflicts of interest.

Appropriate use criteria of transthoracic echocardiography for suspected pediatric heart disease in outpatient settings have been issued for the first time.

The criteria, a collaboration of nine societies, will appear on the websites of the American College of Cardiology, American Society of Echocardiography, and Society for Cardiovascular Angiography and Interventions.

“Of the various diagnostic modalities, echocardiography remains the most readily available, noninvasive, and highly diagnostic tool for assessing cardiac structure, function and hemodynamics in those with suspected cardiac disease,” said Dr. Robert Campbell of Emory University, Atlanta, and his associates. Of the 113 potential indications for first-time use of outpatient transthoracic echocardiography in children and adolescents that they considered, 53 were considered appropriate, 28 possibly appropriate, and 32 rarely appropriate (J. Am. Coll. Cardiol. 2014 Sept. 30 [doi:10.1016/j.jacc.2014.08.003]). The report addressed conditions such as arrhythmias and palpitations, syncope, murmurs, and systemic disorders.

The group collaborated with an Appropriate Use Criteria (AUC) task force and an independent rating panel to produce the report. The criteria do not address posttest follow-up, inpatient pediatric echocardiography, or the assessment of children with known cardiac abnormalities, the authors said.

The writing group reported no funding sources or conflicts of interest. Three members of the rating panel and one member of the AUC task force reported financial relationships with Siemens Medical Systems or Excellus BCBS.

Appropriate use criteria of transthoracic echocardiography for suspected pediatric heart disease in outpatient settings have been issued for the first time.

The criteria, a collaboration of nine societies, will appear on the websites of the American College of Cardiology, American Society of Echocardiography, and Society for Cardiovascular Angiography and Interventions.

“Of the various diagnostic modalities, echocardiography remains the most readily available, noninvasive, and highly diagnostic tool for assessing cardiac structure, function and hemodynamics in those with suspected cardiac disease,” said Dr. Robert Campbell of Emory University, Atlanta, and his associates. Of the 113 potential indications for first-time use of outpatient transthoracic echocardiography in children and adolescents that they considered, 53 were considered appropriate, 28 possibly appropriate, and 32 rarely appropriate (J. Am. Coll. Cardiol. 2014 Sept. 30 [doi:10.1016/j.jacc.2014.08.003]). The report addressed conditions such as arrhythmias and palpitations, syncope, murmurs, and systemic disorders.

The group collaborated with an Appropriate Use Criteria (AUC) task force and an independent rating panel to produce the report. The criteria do not address posttest follow-up, inpatient pediatric echocardiography, or the assessment of children with known cardiac abnormalities, the authors said.

The writing group reported no funding sources or conflicts of interest. Three members of the rating panel and one member of the AUC task force reported financial relationships with Siemens Medical Systems or Excellus BCBS.

Appropriate use criteria of transthoracic echocardiography for suspected pediatric heart disease in outpatient settings have been issued for the first time.

The criteria, a collaboration of nine societies, will appear on the websites of the American College of Cardiology, American Society of Echocardiography, and Society for Cardiovascular Angiography and Interventions.

“Of the various diagnostic modalities, echocardiography remains the most readily available, noninvasive, and highly diagnostic tool for assessing cardiac structure, function and hemodynamics in those with suspected cardiac disease,” said Dr. Robert Campbell of Emory University, Atlanta, and his associates. Of the 113 potential indications for first-time use of outpatient transthoracic echocardiography in children and adolescents that they considered, 53 were considered appropriate, 28 possibly appropriate, and 32 rarely appropriate (J. Am. Coll. Cardiol. 2014 Sept. 30 [doi:10.1016/j.jacc.2014.08.003]). The report addressed conditions such as arrhythmias and palpitations, syncope, murmurs, and systemic disorders.

The group collaborated with an Appropriate Use Criteria (AUC) task force and an independent rating panel to produce the report. The criteria do not address posttest follow-up, inpatient pediatric echocardiography, or the assessment of children with known cardiac abnormalities, the authors said.

The writing group reported no funding sources or conflicts of interest. Three members of the rating panel and one member of the AUC task force reported financial relationships with Siemens Medical Systems or Excellus BCBS.

In its largest randomized controlled trial to date, fenoldopam did not lessen the need for dialysis after cardiac surgery and caused significantly more hypotension than did placebo, investigators reported at the annual congress of the European Society of Intensive Care Medicine.

Acute kidney injury is a common complication of cardiac surgery, and no drugs are known to effectively treat it, said Dr. Tiziana Bove of IRCCS San Raffaele Scientific Institute in Milan. “Given the cost of fenoldopam, the lack of effectiveness, and the increased incidence of hypotension, the use of this agent for renal protection in these patients is not justified,” said Dr. Bove and her associates.

The findings were published in JAMA simultaneously with the presentation at the congress ( 2014 Sept 29 [doi: 10.1001/jama.2014.13573]).

Fenoldopam is a selective dopamine receptor D₁ agonist and vasodilator. For the study, 667 patients who had developed early acute kidney injury after cardiac surgery received either an intravenous continuous infusion of fenoldopam at a starting dose of 0.1 mcg/kg per minute or placebo, the investigators said. Rates of dialysis and 30-day mortality were similar between the two groups. In all, 20% of the treatment group received renal replacement therapy, compared with 18% of the placebo group, and 30-day mortality rates were 23% and 22%, respectively, they said. Furthermore, hypotension developed in 26% of treated patients, compared with 15% of the placebo group (P = .001), the researchers said. The study was stopped for futility after an interim analysis, the researchers noted.The Italian Ministry of Health funded the study. Teva supplied the study drug. The authors reported no conflicts of interest.

In its largest randomized controlled trial to date, fenoldopam did not lessen the need for dialysis after cardiac surgery and caused significantly more hypotension than did placebo, investigators reported at the annual congress of the European Society of Intensive Care Medicine.

Acute kidney injury is a common complication of cardiac surgery, and no drugs are known to effectively treat it, said Dr. Tiziana Bove of IRCCS San Raffaele Scientific Institute in Milan. “Given the cost of fenoldopam, the lack of effectiveness, and the increased incidence of hypotension, the use of this agent for renal protection in these patients is not justified,” said Dr. Bove and her associates.

The findings were published in JAMA simultaneously with the presentation at the congress ( 2014 Sept 29 [doi: 10.1001/jama.2014.13573]).

Fenoldopam is a selective dopamine receptor D₁ agonist and vasodilator. For the study, 667 patients who had developed early acute kidney injury after cardiac surgery received either an intravenous continuous infusion of fenoldopam at a starting dose of 0.1 mcg/kg per minute or placebo, the investigators said. Rates of dialysis and 30-day mortality were similar between the two groups. In all, 20% of the treatment group received renal replacement therapy, compared with 18% of the placebo group, and 30-day mortality rates were 23% and 22%, respectively, they said. Furthermore, hypotension developed in 26% of treated patients, compared with 15% of the placebo group (P = .001), the researchers said. The study was stopped for futility after an interim analysis, the researchers noted.The Italian Ministry of Health funded the study. Teva supplied the study drug. The authors reported no conflicts of interest.

In its largest randomized controlled trial to date, fenoldopam did not lessen the need for dialysis after cardiac surgery and caused significantly more hypotension than did placebo, investigators reported at the annual congress of the European Society of Intensive Care Medicine.

Acute kidney injury is a common complication of cardiac surgery, and no drugs are known to effectively treat it, said Dr. Tiziana Bove of IRCCS San Raffaele Scientific Institute in Milan. “Given the cost of fenoldopam, the lack of effectiveness, and the increased incidence of hypotension, the use of this agent for renal protection in these patients is not justified,” said Dr. Bove and her associates.

The findings were published in JAMA simultaneously with the presentation at the congress ( 2014 Sept 29 [doi: 10.1001/jama.2014.13573]).

Fenoldopam is a selective dopamine receptor D₁ agonist and vasodilator. For the study, 667 patients who had developed early acute kidney injury after cardiac surgery received either an intravenous continuous infusion of fenoldopam at a starting dose of 0.1 mcg/kg per minute or placebo, the investigators said. Rates of dialysis and 30-day mortality were similar between the two groups. In all, 20% of the treatment group received renal replacement therapy, compared with 18% of the placebo group, and 30-day mortality rates were 23% and 22%, respectively, they said. Furthermore, hypotension developed in 26% of treated patients, compared with 15% of the placebo group (P = .001), the researchers said. The study was stopped for futility after an interim analysis, the researchers noted.The Italian Ministry of Health funded the study. Teva supplied the study drug. The authors reported no conflicts of interest.