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

• Status: Completed
• Trial end date: 2006-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Summa Health System
• Treatments: Fenoldopam

Criteria

Inclusion Criteria:

Patients undergoing CABG, CABG/valve operations must meet one of the following:

• Age greater than 70

• Preoperative (within one week) creatinine > or = 1.3

• Insulin depenent diabetes

• NYHA CHF class 3 or 4

• Bypass time anticipated to be greater than 3 hours

• Redo coronary artery bypass grafting

• Low cardiac output states -need for inotropic agents or IABP preoperatively

Exclusion Criteria:

• Emergent operations

• Preopertive liver failure

• Preopertive acute or chronic dialysis dependence

• Known allergy to Fenoldopam

• Patients in whom usage of dopaminergic medications are contraindicated

• Age less than 30

• Caridac surgery without cardiopulmonary bypass

• Patients acively participating in other clinical trials

• Usage of dopaminergic medication