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


METHODS
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.


METHODS
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).


METHODS
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.


METHODS
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.


CONCLUSIONS
The selective dopamine-1 agonist fenoldopam mesylate does not prevent further renal function deterioration after contrast administration in patients with chronic renal insufficiency.
Department of Cardiology, Cardiovascular Research Foundation and Lenox Hill Heart and Vascular Institute, New York, NY 10022, USA. gstone@crf.org
Gregg W
GW
Stone
Peter A
PA
McCullough
James A
JA
Tumlin
Norman E
NE
Lepor
Hooman
H
Madyoon
Patrick
P
Murray
Andrew
A
Wang
A Alan
AA
Chu
Gary L
GL
Schaer
Melissa
M
Stevens
Robert L
RL
Wilensky
William W
WW
O'Neill
D000328:Adult; D000368:Aged; D000792:Angiography; D015906:Angioplasty, Balloon, Coronary; D003287:Contrast Media / Q000009:adverse effects*; D003404:Creatinine / Q000097:blood; D018491:Dopamine Agonists / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D018818:Fenoldopam / Q000627:therapeutic use*; D006331:Heart Diseases / Q000150:complications* / Q000175:diagnosis / Q000628:therapy; D006801:Humans; D017613:Iodine Compounds / Q000009:adverse effects*; D007674:Kidney Diseases / Q000139:chemically induced* / Q000517:prevention & control*; D007676:Kidney Failure, Chronic / Q000150:complications*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D014665:Vasodilator Agents / Q000627:therapeutic use*
D003287:Contrast Media; D018491:Dopamine Agonists; D017613:Iodine Compounds; D014665:Vasodilator Agents; D003404:Creatinine; D018818:Fenoldopam