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ISRCTN
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ISRCTN59467488
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ClinicalTrials.gov identifier
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Public title
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The effect of brain temperature on neuropsychological outcome following cardiopulmonary bypass
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Scientific title
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The effect of brain temperature on neuropsychological outcome following cardiopulmonary bypass: a single centre, two arm, randomised parallel trial
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Acronym
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NPSYCH2
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Serial number at source
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MCT-38146
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Study hypothesis
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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.
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Ethics approval
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Human Research Ethics Board, University of Ottawa Heart Institute, Ottawa, Ontario (Canada) approved on the 27th April 2004 (ref: #UOHI 00-113)
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Study design
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Single centre, two arm, randomised parallel trial with study participant and investigator, outcome assessor, and data analyst blinded
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Countries of recruitment
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Canada
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Disease/condition/study domain
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Cognitive deficits following cardiopulmonary bypass
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Participants - inclusion criteria
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Male or female 60 years or older undergoing coronary artery surgery utilising cardiopulmonary bypass.
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Participants - exclusion criteria
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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
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Anticipated start date
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01/08/1995
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Anticipated end date
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01/02/1998
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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334
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Interventions
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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
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Primary outcome measure(s)
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The incidence of cognitive deficits at 5 - 7 days after surgery.
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Secondary outcome measure(s)
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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
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Sources of funding
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Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-38146)
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Trial website
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Publications
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Results in:
1. 2001 neuroprotective effect results: http://www.ncbi.nlm.nih.gov/pubmed/11568036
2. 2007 five-year follow-up results: http://www.ncbi.nlm.nih.gov/pubmed/17467430
3. 2007 neurocognitive function results: http://www.ncbi.nlm.nih.gov/pubmed/18023662
4. 2009 renal function results: http://www.ncbi.nlm.nih.gov/pubmed/19161766
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Contact name
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Dr
Howard
Nathan
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Address
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Ottawa Heart Institute
40 Ruskin St H341
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City/town
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Ottawa
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Zip/Postcode
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K1Y 4W7
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Country
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Canada
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Tel
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613-761-4775
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Fax
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613-761-4734
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Email
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hnathan@ottawaheart.ca
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Sponsor
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University of Ottawa Heart Institute (Canada)
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Address
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40 Ruskin St H341
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City/town
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Ottawa
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Zip/Postcode
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K1Y 4W7
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Country
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Canada
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Tel
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+1 613 761 4775
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Fax
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+1 613 761 4734
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Email
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hnathan@ottawaheart.ca
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Date applied
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15/10/2004
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Last edited
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03/03/2009
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Date ISRCTN assigned
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23/06/2005
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