ESICM: Fenoldopam Offers Limited Benefit After Cardiac Sx
Study stopped early for futility; no reduction in need for renal replacement therapy, 30-day mortality risk
MONDAY, Sept. 29, 2014 (HealthDay News) -- For critically ill cardiac surgery patients, fenoldopam does not reduce the need for renal replacement therapy, according to a study published online Sept. 29 in the Journal of the American Medical Association. The study was published to coincide with the annual meeting of the European Society of Intensive Care Medicine, held from Sept. 27 to Oct. 1 in Barcelona, Spain.
Tiziana Bove, M.D., from San Raffaele Scientific Institute in Milan, and colleagues examined whether fenoldopam reduces the need for renal replacement therapy in a multicenter randomized double-blind trial. Critically ill cardiac surgery patients with acute kidney injury were randomized to receive fenoldopam (338 patients) or placebo (329 patients). All patients completed follow-up at 30 days after surgery.
After a planned interim analysis, the study was stopped early for futility. The researchers found that 20 and 18 percent of the fenoldopam and placebo groups, respectively, received renal replacement therapy (P = 0.47). Thirty-day mortality was 23 and 22 percent, respectively, in the fenoldopam and placebo groups (P = 0.86). Hypotension occurred in 26 and 15 percent of the fenoldopam and placebo groups, respectively (P = 0.001).
"Among patients with acute kidney injury after cardiac surgery, fenoldopam infusion, compared with placebo, did not reduce the need for renal replacement therapy or risk of 30-day mortality but was associated with an increased rate of hypotension," the authors write.
The study drug was provided by Teva; one institution received a donation not related to this study from Teva.