Status:
COMPLETED
High-Dose N-Acetylcysteine in Cardiac Surgery
Lead Sponsor:
Austin Health
Conditions:
Cardiac Surgery and Cardiopulmonary Bypass
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
At least 14% of patients develop kidney failure after cardiac surgery. Although this kidney failure can usually be treated effectively, a longer stay in intensive care is often required. While many pa...
Detailed Description
Background Renal impairment following cardiopulmonary bypass is common. 11.4% (1) to 42% (2) of patients with previously normal renal function show a postoperative rise in serum creatinine. While mos...
Eligibility Criteria
Inclusion
- Age above 70 years
- Preexisting renal impairment (preoperative serum creatinine level \>120µmol/L
- New York Heart Association class III/IV or Moderate to poor left ventricular dysfunction
- Valve surgery or complex cardiac surgery
- Redo cardiac surgery
- Insulin-dependent diabetes mellitus
Exclusion
- Age \<18 years
- Known allergy or hypersensitivity to N-acetylcysteine
- Emergency cardiac surgery
- Planned off-pump cardiac surgery
- Enrolled in conflicting research study
- Known blood-borne infectious disease
- Chronic inflammatory disease on immunosuppression
- Chronic moderate to high dose corticosteroid therapy (\>10mg/d prednisone or equivalent)
- End stage renal disease (serum creatinine \>300µmol/L)
- Patients receiving pre-op IV nitrates
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
End Date :
March 1 2006
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00332631
Start Date
August 1 2004
End Date
March 1 2006
Last Update
July 7 2009
Active Locations (1)
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1
Austin Hospital
Melbourne, Victoria, Australia, 3084