Acetylcysteine in the Prevention of Renal Failure After Bypass Surgery

Minneapolis Veterans Affairs Health Care System (VAHCS)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Kidney Failure

Treatments: Drug: N-Acetylcysteine

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT00211653

3212-B

Details and patient eligibility

About

The purpose of this study is to determine if Acetylcysteine is effective in preventing renal failure associated with cardiac surgery

Full 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

Enrollment: 102 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind