The use of perioperative n-acetylcysteine to prevent renal dysfunction in high-risk patients undergoing coronary artery bypass graft surgery with cardiopulmonary bypass

ISRCTN ISRCTN94451985
DOI https://doi.org/10.1186/ISRCTN94451985
Secondary identifying numbers N/A
Submission date
10/05/2005
Registration date
05/07/2005
Last edited
12/11/2007
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Karen Burns
Scientific

375 South Street
London
N6A 4G5
Canada

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typePrevention
Scientific title
Study objectivesTo 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedCoronary artery bypass graft surgery
InterventionWe 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Intravenous N-acetylcysteine
Primary outcome measureThe 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 measuresSecondary 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 study start date01/10/2003
Completion date01/09/2004

Eligibility

Participant type(s)Patient
Age groupSenior
SexBoth
Target number of participants295
Key inclusion criteriaElective 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.
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/10/2003
Date of final enrolment01/09/2004

Locations

Countries of recruitment

  • Canada

Study participating centre

375 South Street
London
N6A 4G5
Canada

Sponsor information

The Physician Services Incorporated Foundation (Canada)
Charity

5160 Yonge Street, Suite 1006
Toronto
M2N 6L9
Canada

ROR logo "ROR" https://ror.org/0385yzn06

Funders

Funder type

Charity

The Physician Services Incorporated Foundation (Canada)

No information available

The Lawson Health Research Institute Internal Research Fund (Canada)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article Results 20/07/2005 Yes No