Condition category
Circulatory System
Date applied
10/05/2005
Date assigned
05/07/2005
Last edited
12/11/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Karen Burns

ORCID ID

Contact details

375 South Street
London
N6A 4G5
Canada

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 measures

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

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

Sponsor information

Organisation

The Physician Services Incorporated Foundation (Canada)

Sponsor details

5160 Yonge Street
Suite 1006
Toronto
M2N 6L9
Canada

Sponsor type

Charity

Website

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

Results - basic reporting

Publication summary

Results in: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16030279&query_hl=7&itool=pubmed_DocSum

Publication citations

  1. 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.

Additional files

Editorial Notes