The effect of brain temperature on neuropsychological outcome following cardiopulmonary bypass

ISRCTN	ISRCTN59467488
DOI	https://doi.org/10.1186/ISRCTN59467488
Protocol serial number	MCT-38146
Sponsor	University of Ottawa Heart Institute (Canada)
Funder	Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-38146)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Howard Nathan
Scientific

Ottawa Heart Institute
40 Ruskin St H341
Ottawa
K1Y 4W7
Canada

Phone	613-761-4775
Email	hnathan@ottawaheart.ca

Primary study design	Interventional
Study design	Single centre, two arm, randomised parallel trial with study participant and investigator, outcome assessor, and data analyst blinded
Secondary study design	Randomised controlled trial
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(s)	The incidence of cognitive deficits at 5 - 7 days after surgery.
Key secondary outcome measure(s)	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
Completion date	01/02/1998

Participant type(s)	Patient
Age group	Senior
Sex	All
Target sample size at registration	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

Ottawa Heart Institute

Ottawa
K1Y 4W7
Canada

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	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