Effects of fenoldopam infusion in complex cardiac surgical operations: a prospective, randomized, double-blind, placebo-controlled study

Abstract

Aim: Fenoldopam mesylate is a short-acting dopamine-1 agonist that has been suggested to be a possible reno-protective agent in patients undergoing cardiac surgery. The present study is a prospective, randomized, double-blind placebo controlled trial conducted to determine the effects of fenoldopam in a population of patients undergoing complex cardiac operations.

Methods: Eighty subjects undergoing complex cardiac operations with cardiopulmonary bypass (CPB) were enrolled in the study. Patients were randomly assigned either to the fenoldopam (0.1 microg . kg-1. min-1) or the placebo group. Fenoldopam infusion started at the onset of CPB and was maintained for the first twelve postoperative hours. CPB parameters and renal outcome data were collected.

Results: Patients in the fenoldopam group had higher oxygen delivery during CPB and a significantly lower perfusion pressure, although this parameter was still within the normal range. Blood lactate concentrations during CPB were similar in the two groups. Urine output during and after CPB did not differ between groups, nor did the renal function parameters. There was a significantly higher rate of acute kidney injury (AKI) in the placebo group (10% vs 0%). In the subgroup of patients requiring inotropic support for more than 48 hours, renal function parameters were significantly better, the peak arterial blood lactate was significantly lower, and the major morbidity rate was significantly lower (36% vs 100%) for patients who received fenoldopam.

Conclusion: Fenoldopam improves the quality of perfusion during CPB. In patients receiving catecholamines to treat a postoperative low cardiac output state, fenoldopam significantly improves renal function and prevents AKI and major morbidity.

Trial registration: ClinicalTrials.gov NCT00747331.