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

Completed · Phase 2

Conditions studied: Cardiac Surgery With Cardiopulmonary Bypass

In brief

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.

Key facts

Study ID

NCT00467181

Run by

Summa Health System

People needed

30

Starts

2005-01-01

Expected to finish

2006-04-01

Last updated by the study team

2008-01-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Summa Health System — Akron, Ohio, United States

Full record on ClinicalTrials.gov

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