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Fenoldopam Mesylate for the Prevention of Contrast-Induced Nephropathy: A Randomized Controlled Trial

Fenoldopam Mesylate for the Prevention of Contrast-Induced Nephropathy: A Randomized Controlled Trial

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

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

PMID: 14600187

Abstract:

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 microg/kg/min titrated to 0.10 microg/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.

Chemicals Related in the Paper:

Catalog Number	Product Name	Structure	CAS Number	Price
AP67227570-A	Fenoldopam mesylate		67227-57-0	Price

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