An Investigation of N-acetylcysteine and Fenoldopam as Renal Protection Agents for Cardiac Surgery

• Status: Completed
• Trial end date: 2006-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Patients with abnormal kidney function are at increased risk for complications following heart surgery, including worsening kidney function possibly requiring dialysis, a prolonged stay in the critical care unit and hospital, and the increased risk of death. Prior attempts at kidney protection for heart surgery patients have had mixed results. Two medicines, fenoldopam and N-acetylcysteine, have been shown to protect kidney function in other circumstances that cause kidney stress. The purpose of this study is to determine whether these medications will help to maintain the function of diseased kidneys during heart surgery.

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

Details

• Lead Sponsor: Linda F. Barr, M.D.
• Collaborator: Abbott
• Treatments: Acetylcysteine; Fenoldopam; N-monoacetylcystine

Criteria

Inclusion Criteria:

• Chronic creatinine clearance
• Pre-operative cardiac surgery

Exclusion Criteria:

• Pre-operative ongoing dialysis

• Nausea and vomiting

• Uncontrolled glaucoma

• Allergy to metabisulfite

• Enrollment in another clinical study within 30 days

• Pregnancy

• Acute renal failure