Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
To determine whether perioperative intravenous (IV) N-acetylcysteine preserves renal function in high-risk patients undergoing Coronary Artery Bypass Graft (CABG) surgery with Cardiopulmonary Bypass (CPB) compared with placebo.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Condition
Coronary artery bypass graft surgery
Intervention
We randomized patients to receive four (two intraoperative and two postoperative) doses of intravenous N-acetylcysteine 600 mg or placebo over a 24-hour period.
Intervention type
Drug
Phase
Not Specified
Drug names
Intravenous N-acetylcysteine
Primary outcome measure
The primary outcome was the proportion of patients developing postoperative renal dysfunction, defined by an increase in serum creatinine level greater than 0.5 mg/dL (44 micromol/L) or a 25% increase from baseline within the first 5 postoperative days.
Secondary outcome measures
Secondary outcomes included postoperative interventions and complications, the requirement for renal replacement therapy (RRT), adverse events, hospital mortality, and ICU and hospital length of stay.
Overall trial start date
01/10/2003
Overall trial end date
01/09/2004
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Elective or urgent coronary artery bypass graft surgery patients with at least one of: pre-esisting renal dysfunction, age greater than or equal to 70, diabetes mellitus, impaired left ventricular function or undergoing concomitant valve or redo surgery.
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
295
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/10/2003
Recruitment end date
01/09/2004
Locations
Countries of recruitment
Canada
Trial participating centre
375 South Street
London
N6A 4G5
Canada
Funders
Funder type
Charity
Funder name
The Physician Services Incorporated Foundation (Canada)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The Lawson Health Research Institute Internal Research Fund (Canada)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
Publication citations
-
Results
Burns KE, Chu MW, Novick RJ, Fox SA, Gallo K, Martin CM, Stitt LW, Heidenheim AP, Myers ML, Moist L, Perioperative N-acetylcysteine to prevent renal dysfunction in high-risk patients undergoing cabg surgery: a randomized controlled trial., JAMA, 2005, 294, 3, 342-350, doi: 10.1001/jama.294.3.342.