drugset / Trial / NCT00467181

A Pilot Study to Investigate Fenoldopam Usage in the Prevention of Postoperative Renal Dysfunction in Patients at a High Risk for Renal Impairment During Cariopulmonary Bypass for Cardiac Surgery

NCT00467181

Phase 2 Completed 30 enrolled Summa Health System
RandomizedParallel-groupSingle-blindTreatment

Summary

The Primary objective is to reduce the incidence of postoperative renal dysfunction in a high-risk subset of patients undergoing cardiac surgery on cardiopulmonary bypass with Fenolopam, a selective dopamine-1 receptor agonist. Perioperative renal function will be observed in 3 randomly selected groups of patients-Fenoldopam infusion at 0.03 cg/kg/min, Fenoldopam at 0.1 mcg/kg/min or placebo Secondary objective: will be to correlate Fenoldopam usage with postoperative clinical outcomes such as ICU stay, hospital stay, need for inotropes/vasopressors, need for diuretics, requirements for ECF at discharge, and overall perioperative cost reduction through decreased ICU and hospital length of stay.

Timeline

Start
2005-01
Primary completion
2006-04
Completion
2006-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Fenoldopam Small molecule 0.03 ug/kg Intravenous
Subject Fenoldopam Small molecule 0.1 ug/kg Intravenous

Indications

No indication recorded.