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Study: Kidney Drug Fenoldopam (Corlopam) Does Not Reduce Need for Dialysis
Among patients with acute kidney injury after cardiac surgery, infusion with the antihypertensive agent fenoldopam (Corlopam, Hospira) did not reduce the need for dialysis or the risk of death at 30 days compared with placebo, but was associated with an increased rate of abnormally low blood pressure, according to a study published September 29 in JAMA.
The report was posted early online to coincide with its presentation at the European Society of Intensive Care Medicine (ESICM) annual congress, held September 27–October 1 in Barcelona, Spain.
More than 1 million patients undergo cardiac surgery each year in the U.S. and Europe. One of the most common complications of this surgery is acute kidney injury. Because of its hemodynamic effects, fenoldopam has been widely promoted for the prevention and therapy of acute kidney injury, with apparent favorable results in cardiac surgery. However, the absence of a definitive trial leaves clinicians uncertain as to whether fenoldopam should be prescribed after cardiac surgery to prevent deterioration in kidney function, according to background information in the article.
Tiziana Bove, MD, and her colleagues randomly assigned 667 patients admitted to intensive care units (ICUs) after cardiac surgery with early acute kidney injury to receive either fenoldopam infusion (338 patients) or placebo (329 patients). The study was conducted from March 2008 to April 2013 in cardiovascular ICUs in Italy.
The trial was stopped for futility as recommended by the safety committee after a planned interim analysis. Acute kidney injury progressed after treatment with dialysis in 20% (69/338) of the fenoldopam group compared with 18% (60/329) of the placebo group. The 30-day mortality rate was 23% (78/338) in fenoldopam-treated patients and 22% (74/329) in placebo-treated patients. Hypotension during infusion was experienced by 26% (85/338) of the fenoldopam group and by 15% (49/329) of the placebo group.
“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,” the authors concluded.