Study Design

Study Design:

Patients Enrolled: 315
Mean Follow Up: 30 days
Mean Patient Age: mean age 70 years
Female: 34

Patient Populations:

Age ≥18 years; creatinine clearance of <60 ml/min; and not undergoing dialysis

Exclusions:

Known severe allergy to contrast media that could not be premedicated; known allergy to fenoldopam or its infusion components such as metabisulfite or sulfites; acute renal failure or unstable renal function; systolic blood pressure <100 mm Hg; acute MI or decompensated heart or respiratory failure; contraindication to dopaminergic agents; current use of mannitol or dopamine; planned addition, discontinuation, or dose adjustment of trimethoprim, cimetidine, metoclopramide, bromocriptine, levodopa, nonsteroidal anti-inflammatory drugs, or catechol-O-methyltransferase inhibitors during the study; exposure to iodinated contrast within prior 10 days; other serious medical conditions likely to interfere with data collection or follow-up; or participation in other investigational protocols within 30 days

Primary Endpoints:

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

Secondary Endpoints:

Measurements of contrast-induced nephropathy defined as two consecutive increases in serum creatinine ≥25%, and an increase in serum creatinine ≥0.5 mg/dl; duration of the index hospitalization; and 30-day death, dialysis, and rehospitalization

Drug/Procedures Used:

Patients with creatinine clearance <60 ml/min (1.00 ml/s) were randomized to fenoldopam mesylate (0.05 µg/kg/min titrated to 0.10 µg/kg/min; n=157) or placebo (n=158). Treatment was started one hour prior to angiography and continued for 12 hours.

Concomitant Medications:

After consent was obtained, a 0.45% normal saline infusion was started for 2-12 hours prior to study drug administration.