The effect of brain temperature on neuropsychological outcome following cardiopulmonary bypass
| ISRCTN | ISRCTN59467488 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN59467488 |
| Secondary identifying numbers | MCT-38146 |
- Submission date
- 15/10/2004
- Registration date
- 23/06/2005
- Last edited
- 10/11/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Howard Nathan
Scientific
Scientific
Ottawa Heart Institute
40 Ruskin St H341
Ottawa
K1Y 4W7
Canada
| Phone | 613-761-4775 |
|---|---|
| hnathan@ottawaheart.ca |
Study information
| Study design | Single centre, two arm, randomised parallel trial with study participant and investigator, outcome assessor, and data analyst blinded |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Scientific title | The effect of brain temperature on neuropsychological outcome following cardiopulmonary bypass: a single centre, two arm, randomised parallel trial |
| Study acronym | NPSYCH2 |
| Study objectives | Maintaining mild hypothermia (34°C) compared to normothermia (37°C) throughout the entire intra-operative period will decrease brain injury during coronary artery surgery with cardiopulmonary bypass. |
| Ethics approval(s) | Human Research Ethics Board, University of Ottawa Heart Institute, Ottawa, Ontario (Canada) approved on the 27th April 2004 (ref: #UOHI 00-113) |
| Health condition(s) or problem(s) studied | Cognitive deficits following cardiopulmonary bypass |
| Intervention | Randomisation to maintenance of body and brain temperature constant at 34 °C or 37 °C during the entire intra-operative period. Eleven tests were combined into three cognitive domains: 1. Memory 2. Attention 3. Psychomotor speed and dexterity |
| Intervention type | Other |
| Primary outcome measure | The incidence of cognitive deficits at 5 - 7 days after surgery. |
| Secondary outcome measures | 1. Incidence of cerebral emboli during cardiopulmonary bypass (CPB) as measured by trans-cranial doppler 2. Quality of life at 3 months and the incidence of cognitive deficits at 3 months |
| Overall study start date | 01/08/1995 |
| Completion date | 01/02/1998 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 334 |
| Key inclusion criteria | Male or female 60 years or older undergoing coronary artery surgery utilising cardiopulmonary bypass. |
| Key exclusion criteria | 1. Emergency surgery 2. Unable to undergo cognitive testing (visual or motor problems, unable to speak French or English) 3. Mini Mental State Examination (MMSE) less than 24 (dementia) 4. Patients undergoing other cardiac procedures in addition to coronary artery bypass graft (CABG) or reoperation 5. Patients with Parkinson's disease or a history of stroke 6. Age less than 60 7. Patients with renal insufficiency (creatinine 2 x normal) or hepatic insufficiency |
| Date of first enrolment | 01/08/1995 |
| Date of final enrolment | 01/02/1998 |
Locations
Countries of recruitment
- Canada
Study participating centre
Ottawa Heart Institute
Ottawa
K1Y 4W7
Canada
K1Y 4W7
Canada
Sponsor information
University of Ottawa Heart Institute (Canada)
University/education
University/education
40 Ruskin St H341
Ottawa
K1Y 4W7
Canada
| Phone | +1 613 761 4775 |
|---|---|
| hnathan@ottawaheart.ca | |
"ROR" |
https://ror.org/03c4mmv16 |
Funders
Funder type
Research organisation
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-38146)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | neuroprotective effect results | 18/09/2001 | Yes | No | |
| Results article | five-year follow-up results | 01/05/2007 | Yes | No | |
| Results article | neurocognitive function results: | 01/12/2007 | Yes | No | |
| Results article | renal function results | 01/02/2009 | Yes | No | |
| Results article | cognitive dysfunction results | 01/10/2010 | Yes | No |
