N-Acetylcysteine for Preventing Renal Injury After Cardiac Surgery

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00188630
• Date of registration: 09/09/2005
• Primary sponsor: University Health Network, Toronto
• Public title: N-Acetylcysteine for Preventing Renal Injury After Cardiac Surgery
• Scientific title: The PRIME (Perioperative Renal Insufficiency Management) Study: A Randomized, Double-blinded, Placebo-controlled Trial of N-acetylcysteine for Preventing Renal Injury After Cardiac Surgery.
• Date of first enrolment: July 2003
• Target sample size: 176
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00188630
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Countries of recruitment

Canada

Contacts

• Name: William S Beattie, MD
• Affiliation: Toronto General Hospital, University Health Network

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 Criteria:

- 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Acute Renal Failure

Heart Disease

Intervention(s)

Drug: N-acetylcysteine

Other: 5% dextrose solution

Primary Outcome(s)

Maximum percent decline in calculated creatinine clearance (Cockcroft-Gault formula) in first 72 hours following surgery. [Time Frame: 72 hours following surgery]

Secondary Outcome(s)

24-hour fluid perioperative fluid balance [Time Frame: 24 hours]

24-hour urine output [Time Frame: 24 hour]

30-day all-cause mortality [Time Frame: 30 day follow up]

30-day need for renal replacement therapy [Time Frame: 30 day inclusive]

Adverse perioperative event [Time Frame: Intra operative measure]

Increase in serum creatinine >= 0.5 mg/dL from baseline over first 72 hours following surgery (dichotomous outcome). [Time Frame: 72 hours following surgery]

Length of stay in hospital (postoperative) [Time Frame: Until discharge form hospital]

Length of stay in intensive care unit (postoperative) [Time Frame: Duration of stay in the ICU]

Maximum increase in serum creatinine concentration over first 72 hours following surgery. [Time Frame: 72 hours following surgery]

Maximum percent decline in calculated creatinine clearance (Cockcroft-Gault formula) >= 25% in first 72 hours following surgery (dichotomous outcome). [Time Frame: 72 hours following surgery]

Maximum percent decline in calculated creatinine clearance (Cockcroft-Gault formula) at 8 weeks following surgery. [Time Frame: 8 weeks followiing surgery]

Percent change in calculated creatinine clearance (Cockcroft-Gault formula) at hospital discharge. [Time Frame: hospital discharge]

Secondary ID(s)

HSFO5231

UHN REB 03-0376-B

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Heart and Stroke Foundation of Ontario