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 |
| Protocol serial number | N/A |
| Sponsor | The Physician Services Incorporated Foundation (Canada) |
| Funders | The Physician Services Incorporated Foundation (Canada), The Lawson Health Research Institute Internal Research Fund (Canada) |
- 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
Scientific
375 South Street
London
N6A 4G5
Canada
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Intravenous N-acetylcysteine |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
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. |
| Completion date | 01/09/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | All |
| Target sample size at registration | 295 |
| Key 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. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/10/2003 |
| Date of final enrolment | 01/09/2004 |
Locations
Countries of recruitment
- Canada
Study participating centre
375 South Street
London
N6A 4G5
Canada
N6A 4G5
Canada
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 |
