ACTRN12606000088549
Recruiting
Phase 3
Preoperative intranenous N-Acetylcysteine for the prevention of renal failure in patients with renal impairment undergoing cardiac surgery
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Renal Impairment in cardiac surgery
- Sponsor
- Prince of Wales Hospital
- Enrollment
- 200
- Status
- Recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Patients with chronic stable renal impairment as evidenced by a creatinine \>133µmol//L or creatinine clearance \< 50ml/min as estimated by the Cockcroft\- Gault formula20\. ( Creatinine clearance or CrCl will be calculated by applying the Cockcroft\- Gault formula to the baseline serum creatinine level: (140 – age) x weight/ serum creatinine x 0\.815; with a female adjustment: CrCl female \= CrCl x 0\.85\)2\. Patients undergoing cardiac surgery requiring cardiopulmonary bypass including but not exclusive to coronary artery bypass grafting (CABG), valve surgery, combination CABG and valve replacement procedures, adult patients undergoing surgery for congenital heart disease, repairs of ventricular aneurysm, septal defect repairs and removal of myxomas, stable patients with intraaortic balloon pump (IABP) inserted electively preoperatively, redo cases requiring cardiopulmonary bypass (CPB). 3\. Patients who have given consent.
Exclusion Criteria
- •1\. Females of child bearing age in whom pregnancy has not been disproved, are pregnant or lactating. 2\. Haemodynamically unstable patients with SBP\< 90mmHg preoperatively. 3\. Patients with acute renal failure. 4\. Patients receiving haemodialysis or peritoneal dialysis. 5\. Treatment with nonsteroidal anti\-inflammatory agents (NSAIDs) within previous 4 days. 6\. Patients allergic to acetylcysteine. 7\. Patients with current acute exacerbations of asthma or chronic obstructive pulmonary disease. 8\. Impaired liver function. 9\. Renal transplant patients.10\. Failure to consent.
Outcomes
Primary Outcomes
Not specified
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