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A Randomized Controlled Trial

Gregg W. Stone, MD; Peter A. McCullough, MD, MPH; James A. Tumlin, MD; Norman E. Lepor, MD; Hooman Madyoon, MD; Patrick Murray, MD; Andrew Wang, MD; A. Alan Chu, MD; Gary L. Schaer, MD; Melissa Stevens, MD; Robert L. Wilensky, MD; William W. O'Neill, MD; for the CONTRAST Investigators

JAMA. 2003;290:2284-2291.

Context  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.

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

Design  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.

Patients and Setting  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).

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

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

Results  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.

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

Author Affiliations: Department of Cardiology, Cardiovascular Research Foundation and Lenox Hill Heart and Vascular Institute, New York, NY (Dr Stone); Department of Cardiology, William Beaumont Hospital, Royal Oak, Mich (Drs McCullough, Stevens, and O'Neill); Department of Nephrology, Emory University School of Medicine, Atlanta, Ga (Dr Tumlin); Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles, Calif (Dr Lepor); Department of Cardiology, St Joseph's Medical Center, Stockton, Calif (Dr Madyoon); Department of Cardiology, University of Chicago, Chicago, Ill (Dr Murray); Department of Cardiology, Duke University Medical Center, Durham, NC (Dr Wang); Department of Cardiology, Saint Francis Medical Center, Peoria, Ill (Dr Chu); Department of Cardiology, Rush-Presbyterian-St Luke's Medical Center, Chicago, Ill (Dr Schaer); and Department of Cardiology, Hospital of the University of Pennsylvania, Philadelphia (Dr Wilensky).

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