Fenoldopam ineffective for renal injury after cardiac surgery

1. Fenoldopam did not significantly improve mortality or reduce dialysis initiation in patients with acute kidney injury (AKI) after cardiac surgery.

2. The patients receiving fenoldopam had significantly higher rates of hypotension than the control group.

Evidence Rating Level: 1 (Excellent)

Study Rundown: Acute kidney injury (AKI) is a common post-operative complication after cardiac surgery and is associated with high mortality rates in those who require renal replacement therapy, or dialysis. This study sought to demonstrate whether fenoldopam, a selective dopamine receptor D1 agonist that functions as an arterial vasodilator, would help perfusion of the kidneys after cardiac surgery and decrease the incidence of dialysis in these patients. The study was stopped early due to futility because there was no significant change in mortality or incidence of dialysis. The experimental group also had significantly higher frequency of hypotension.

While strengths of this study include the fact that this study is the largest randomized controlled trial that has examined the role of fenoldopam in AKI prevention, a limitation is its early discontinuation. These study results differ from the results of previous studies that showed that administration of fenoldopam can be beneficial in reducing risk of AKI and need for dialysis. Although the results showed a harmful effect of fenoldopam, there is still the question of whether fenoldopam may be beneficial when hypotension can be avoided. More studies will need to be done in order to elucidate the beneficial and harmful effects of fenoldopam in patients at high-risk of AKI.

Click to read the study, published today in JAMA

Relevant Reading: Effects of fenoldopam infusion in complex cardiac surgical operations: a prospective, randomized, double-blind, placebo-controlled study

In-Depth [randomized, controlled study]: This study was a 19-center, randomized, placebo-controlled, and double-blinded study that randomized 667 patients in the ICU after cardiac surgery to receive an infusion of fenoldopam mesylate or placebo for 96 hours, until ICU discharge, or death. Patients were excluded if they had contraindications to receiving fenoldopam (such as glaucoma) or if they had required renal replacement therapy pre-operatively or in the past. Doses of fenoldopam ranged from 0.05 mcg/kg/min to 0.3 mcg/kg/min and were titrated to avoid hypotension, defined clinically at bedside. Initiation of dialysis was also at the discretion of the clinician.

The primary endpoint was the incidence of dialysis initiation while in the ICU. Secondary endpoints included ICU mortality, 30-day mortality, hours of time on ventilation, length of ICU and hospital stay, peak serum creatinine and the incidence of AKI as defined by the RIFLE score. Mean dose of fenoldopam administered was 0.12 mcg/kg/min. Twenty percent of patients in the fenoldopam group progressed to dialysis vs. 18% in the placebo group (p=0.47). There was no significant difference in ICU (p=0.87) or hospital mortality (p=0.86). Sub-group analysis of high-dose fenoldopam use did not alter the results. The experimental group experienced significantly higher rates of hypotension compared to the control group (26% vs. 15%, p=0.001).

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