Single Center Randomized Clinical Trial of the Effects of Acetylcysteine in the Prevention of Postoperative Renal Failure
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Kidney Failure
- Sponsor
- Minneapolis Veterans Affairs Medical Center
- Enrollment
- 102
- Locations
- 1
- Primary Endpoint
- Rise in creatinine above baseline
- Status
- Completed
- Last Updated
- 18 years ago
Overview
Brief Summary
The purpose of this study is to determine if Acetylcysteine is effective in preventing renal failure associated with cardiac surgery
Detailed Description
Postoperative renal dysfunction is a predictor of significant morbidity and mortality among patients undergoing cardiac surgery. The mortality associated with coronary artery by-pass surgery increases from 2% to almost 19% in patients with renal failure and approaches 60% in patients who require hemodialysis. Patients with preoperative renal dysfunction referred for coronary artery by pass surgery have an extraordinarily high risk of requiring postoperative dialysis. For example, among those patients with preoperative creatinine \>2.5 mg/dL, almost 50% require hemodialysis. Comparison: N-Acetylcysteine is superior to placebo in preventing renal failure after cardiac surgery
Investigators
Eligibility Criteria
Inclusion Criteria
- •Pts with baseline chronic kidney disease (eGFR\<60 ml/min/1.73m2)undergoing cardiac surgery
Exclusion Criteria
- •Patients on hemodialysis preoperatively
- •IV contrast within 4 days prior to surgery
- •Urgent/emergent surgery
- •History of renal transplantation
Outcomes
Primary Outcomes
Rise in creatinine above baseline
Time Frame: 7 days postoperatively
Secondary Outcomes
- Creatinine increase >25% or =/> 0.5 mg/dl above baseline(Postoperative days 5, 7 and 30)
- Length of stay in the ICU and the hospital
- Operative mortality(30-day)