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JAMA. 2003 Nov 5;290(17):2284-91.

Fenoldopam mesylate for the prevention of contrast-induced nephropathy: a randomized controlled trial.

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  • 1Department of Cardiology, Cardiovascular Research Foundation and Lenox Hill Heart and Vascular Institute, New York, NY 10022, USA.



The development of contrast-induced nephropathy in patients undergoing invasive cardiac procedures is associated with a marked increase in cardiovascular morbidity and mortality. Fenoldopam mesylate, a specific agonist of the dopamine-1 receptor, preserves renal blood flow after iodinated contrast administration and has shown promise in ameliorating contrast nephropathy in previous observational and small randomized trials.


To examine the efficacy of fenoldopam mesylate in preventing contrast nephropathy after invasive cardiovascular procedures.


Prospective, placebo-controlled, double-blind, multicenter randomized trial with serial serum creatinine levels measured at a central biochemistry laboratory (at baseline and 1, 24, 48, and 72 to 96 hours after study drug administration) and 30-day clinical follow-up.


Between March 2001 and July 2002, 315 patients with creatinine clearance less than 60 mL/min (1.00 mL/s) at 28 centers in the United States were randomized to receive fenoldopam mesylate (n = 157) or placebo (n = 158).


Patients were hydrated and randomized to receive intravenous fenoldopam (0.05 microg/kg/min titrated to 0.10 microg/kg/min) vs matching placebo, starting 1 hour prior to angiography and continuing for 12 hours.


Contrast-induced nephropathy, defined as an increase of 25% or more in serum creatinine level within 96 hours postprocedure.


Mean (SD) patient age was 70 (11) years, and 49% had diabetes mellitus. Mean (SD) baseline creatinine clearance was 29.0 (10.0) mL/min (0.48 [0.16] mL/s) (range, 7.5-56.8 mL/min [0.12-0.94 mL/s]), and 157 (108) mL of contrast was administered during the procedures. The primary end point of contrast-induced nephropathy occurred in 33.6% of patients assigned to receive fenoldopam vs 30.1% assigned to receive placebo (relative risk, 1.11; 95% confidence interval, 0.79-1.57; P =.61). There were no significant differences in the 30-day rates of death (2.0% vs 3.8%, P =.50), dialysis (2.6% vs 1.9%, P =.72), or rehospitalization (17.6% vs 19.9%, P =.66) in fenoldopam vs placebo randomized patients, respectively.


The selective dopamine-1 agonist fenoldopam mesylate does not prevent further renal function deterioration after contrast administration in patients with chronic renal insufficiency.

[PubMed - indexed for MEDLINE]
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