Preoperative intranenous N-Acetylcysteine for the prevention of renal failure in patients with renal impairment undergoing cardiac surgery

Phase 3

Recruiting

• Conditions: Renal Impairment in cardiac surgery; Renal and Urogenital - Other renal and urogenital disorders; Cardiovascular - Other surgery

• Registration Number: ACTRN12606000088549
• Lead Sponsor: Prince of Wales Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-03-01
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified