Status:
COMPLETED
N-Acetylcysteine for Preventing Renal Injury After Cardiac Surgery
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
Heart and Stroke Foundation of Ontario
Conditions:
Heart Disease
Acute Renal Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Cardiac surgery improves the survival and quality of life of people with heart disease. Nonetheless, several complications continue to adversely affect outcomes following cardiac surgery. Kidney failu...
Eligibility Criteria
Inclusion
- CABG surgery under cardiopulmonary bypass AND/OR Valve replacement/repair surgery under cardiopulmonary bypass
- Preoperative creatinine clearance (Cockcroft-Gault equation) \<= 60 mL/min.
- Age above 18 years
- Informed consent
Exclusion
- Preoperative need for renal replacement therapy
- Preoperative serum creatinine concentration \>= 300 mmol/L
- Prior adverse reaction to NAC with significant systemic symptoms (generalized rash, urticaria, bronchospasm, hypotension)
- Preoperative intra-aortic balloon pump support and/or inotropes/vasopressors
- Recent coronary angiography or intravenous dye exposure (\<= 24 hours) preceding surgery
- Planned intraoperative deep hypothermic circulatory arrest
- Pregnancy
- Chronic hepatitis or hepatic cirrhosis
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
176 Patients enrolled
Trial Details
Trial ID
NCT00188630
Start Date
July 1 2003
End Date
July 1 2007
Last Update
April 20 2011
Active Locations (1)
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1
Toronto General Hospital, UHN
Toronto, Ontario, Canada, M5G 2C4