Acetylcysteine in the Prevention of Renal Failure After Bypass Surgery

Kidney Failure Clinical Trial

Official title:

Single Center Randomized Clinical Trial of the Effects of Acetylcysteine in the Prevention of Postoperative Renal Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00211653
• Other study ID #: 3212-B
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 13, 2005
• Last updated: September 18, 2007
• Start date: April 2003
• Est. completion date: November 2006

Study information

• Verified date: September 2007
• Source: Minneapolis Veterans Affairs Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Failure
• Renal Insufficiency

Intervention

Drug:
• N-Acetylcysteine

Locations

Country	Name	City	State
United States	Veterans Affairs Medical Center	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Minneapolis Veterans Affairs Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rise in creatinine above baseline		7 days postoperatively
Secondary	Creatinine increase >25% or =/> 0.5 mg/dl above baseline		Postoperative days 5, 7 and 30
Secondary	Length of stay in the ICU and the hospital
Secondary	Operative mortality		30-day