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Acetylcysteine in the Prevention of Renal Failure After Bypass Surgery

Phase 1
Completed
Conditions
Kidney Failure
Registration Number
NCT00211653
Lead Sponsor
Minneapolis Veterans Affairs Medical Center
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

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
102
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Rise in creatinine above baseline7 days postoperatively
Secondary Outcome Measures
NameTimeMethod
Creatinine increase >25% or =/> 0.5 mg/dl above baselinePostoperative days 5, 7 and 30
Length of stay in the ICU and the hospital
Operative mortality30-day

Trial Locations

Locations (1)

Veterans Affairs Medical Center

🇺🇸

Minneapolis, Minnesota, United States

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