Effect of Fenoldopam on Use of Renal Replacement Therapy Among Patients With Acute Kidney Injury After Cardiac Surgery: A Randomized Clinical Trial

Study Questions:

Does fenoldopam infusion reduce the need for renal replacement therapy, mortality rates, or both among critically ill patients with acute kidney injury following cardiac surgery?


This was a multicenter, prospective, randomized, double-blind, placebo-controlled trial conducted in 19 Italian hospitals from 2008 to 2013. Patients were eligible if they developed acute kidney injury (defined as ≥50% increase of serum creatinine level from baseline or oliguria for ≥6 hours) to receive fenoldopam (338 patients) or placebo (329 patients). In the intervention group, the study drug was administered as a continuous intravenous infusion (starting dose was 0.1 mcg/kg/min) for a total of 96 hours or until intensive care unit (ICU) discharge or death. The primary endpoint was the rate of renal replacement therapy usage in the ICU.


The trial was terminated early because of futility. The need for renal replacement therapy was no different in the study group (n = 69, 20%), compared to the placebo group (n = 60, 18%; p = 0.47). There was no difference in 30-day mortality (23% in the fenoldopam group vs. 22% in the placebo group, p = 0.86). A significantly greater number of patients in the fenoldopam group, compared to the placebo group, experienced hypotension (26% vs. 15%, p = 0.001).


In this placebo-controlled randomized trial of patients with acute kidney injury after cardiac surgery, fenoldopam did not reduce the need for renal replacement therapy or mortality, but was associated with an increased rate of hypotension.


Although this trial was stopped prematurely (for futility), the authors provide convincing evidence to avoid fenoldopam in patients with acute kidney injury following cardiac surgery. It does not appear to confer renal protection, even though its mechanism of benefit (vasodilation of the renal, mesenteric, peripheral, and coronary arteries through action as a selective dopamine receptor D1 agonist) seems physiologically plausible.

Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention

Keywords: Fenoldopam, Intensive Care Units, Acute Kidney Injury, Critical Illness, Hypotension, Medical Futility, Creatinine, Cardiac Surgical Procedures, Oliguria, Renal Replacement Therapy

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