Contact information
Type
Scientific
Primary contact
Dr Howard Nathan
ORCID ID
Contact details
Ottawa Heart Institute
40 Ruskin St H341
Ottawa
K1Y 4W7
Canada
613-761-4775
hnathan@ottawaheart.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MCT-38146
Study information
Scientific title
The effect of brain temperature on neuropsychological outcome following cardiopulmonary bypass: a single centre, two arm, randomised parallel trial
Acronym
NPSYCH2
Study hypothesis
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
Human Research Ethics Board, University of Ottawa Heart Institute, Ottawa, Ontario (Canada) approved on the 27th April 2004 (ref: #UOHI 00-113)
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
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
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 trial start date
01/08/1995
Overall trial end date
01/02/1998
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Male or female 60 years or older undergoing coronary artery surgery utilising cardiopulmonary bypass.
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
334
Participant 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
Recruitment start date
01/08/1995
Recruitment end date
01/02/1998
Locations
Countries of recruitment
Canada
Trial participating centre
Ottawa Heart Institute
Ottawa
K1Y 4W7
Canada
Sponsor information
Organisation
University of Ottawa Heart Institute (Canada)
Sponsor details
40 Ruskin St H341
Ottawa
K1Y 4W7
Canada
+1 613 761 4775
hnathan@ottawaheart.ca
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-38146)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
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
5. 2010 cognitive dysfunction results in http://www.ncbi.nlm.nih.gov/pubmed/20724717
Publication citations
-
Neuroprotective effect results
Nathan HJ, Wells GA, Munson JL, Wozny D, Neuroprotective effect of mild hypothermia in patients undergoing coronary artery surgery with cardiopulmonary bypass: a randomized trial., Circulation, 2001, 104, 12 Suppl 1, I85-91.
-
Neurocognitive function results
Boodhwani M, Rubens F, Wozny D, Rodriguez R, Nathan HJ, Effects of sustained mild hypothermia on neurocognitive function after coronary artery bypass surgery: a randomized, double-blind study., J. Thorac. Cardiovasc. Surg., 2007, 134, 6, 1443-50; discussion 1451-2, doi: 10.1016/j.jtcvs.2007.08.016.
-
Renal function results
Boodhwani M, Rubens FD, Wozny D, Nathan HJ, Effects of mild hypothermia and rewarming on renal function after coronary artery bypass grafting., Ann. Thorac. Surg., 2009, 87, 2, 489-495, doi: 10.1016/j.athoracsur.2008.10.078.
-
Cognitive dysfunction results
Rodriguez RA, Rubens FD, Wozny D, Nathan HJ, Cerebral emboli detected by transcranial Doppler during cardiopulmonary bypass are not correlated with postoperative cognitive deficits., Stroke, 2010, 41, 10, 2229-2235, doi: 10.1161/STROKEAHA.110.590513.
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Nathan HJ, Rodriguez R, Wozny D, Dupuis JY, Rubens FD, Bryson GL, Wells G, Neuroprotective effect of mild hypothermia in patients undergoing coronary artery surgery with cardiopulmonary bypass: five-year follow-up of a randomized trial., J. Thorac. Cardiovasc. Surg., 2007, 133, 5, 1206-1211, doi: 10.1016/j.jtcvs.2006.09.112.