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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12606000088549

Enrollment

200

Registered

2006-03-01

Start date

2004-08-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Patients who fit into Inclusion criteria will be randomised to receive intravenous N-Acetylcestine 150mg/kg for 16 hours.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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.

Outcome results