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The effect of brain temperature on neuropsychological outcome following cardiopulmonary bypass

The effect of brain temperature on neuropsychological outcome following cardiopulmonary bypass: a single centre, two arm, randomised parallel trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN59467488
Enrollment
334
Registered
2005-06-23
Start date
1995-08-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive deficits following cardiopulmonary bypass Injury, Occupational Diseases, Poisoning Brain injury

Interventions

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. A

Sponsors

University of Ottawa Heart Institute (Canada)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Male or female 60 years or older undergoing coronary artery surgery utilising cardiopulmonary bypass.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
The incidence of cognitive deficits at 5 - 7 days after surgery.

Secondary

MeasureTime frame
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

Countries

Canada

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026