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.
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).
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.
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.