Condition category
Injury, Occupational Diseases, Poisoning
Date applied
15/10/2004
Date assigned
23/06/2005
Last edited
10/11/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Additional files

Editorial Notes