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Sponsors and Collaborators: |
UMC Utrecht International Anesthesia Research Society (IARS) |
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Information provided by: | UMC Utrecht |
ClinicalTrials.gov Identifier: | NCT00189215 |
Coronary artery bypass surgery is associated with postoperative cognitive decline, which has largely been attributed to the use of the heart lung machine. We hypothesized that long-term cognitive outcome may improve by avoiding the heart lung machine. The objective of the present study is to compare the effect of coronary bypass surgery with and without heart lung machine on cognitive and clinical outcome, five years after surgery.
Condition | Intervention | Phase |
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Coronary Artery Disease Cardiopulmonary Bypass Cognition Disorders |
Device: cardiac stabilizer instead of cardiopulmonary bypass |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind, Active Control, Parallel Assignment, Safety Study |
Official Title: | Long-Term Cognitive Decline After Coronary Artery Bypass Grafting: is Off-Pump Surgery Beneficial? |
Estimated Enrollment: | 280 |
Study Start Date: | March 1998 |
Estimated Study Completion Date: | December 2005 |
Background:
Coronary artery bypass surgery is associated with postoperative cognitive decline, which has largely been attributed to the use of cardiopulmonary bypass (CPB). A large recent study by Newman et al demonstrated that the incidence of cognitive decline was 24% at six months after surgery, but it increased to 42% at five years. In the recently conducted Octopus Randomized Trial, cognitive decline at three months after surgery was present in 29% of the patients operated with CPB. In the patients operated without CPB, the incidence was 21%, i.e. only slightly better.
Hypothesis:
Improvement of cognitive outcome by avoiding cardiopulmonary bypass will become more apparent five years after surgery, compared to three months after surgery.
Study objectives:
The objective of the present study is to compare the effect of coronary bypass surgery with and without cardiopulmonary bypass on cognitive and clinical outcome, five years after surgery.
Methods:
The 281 participants of the Octopus Study, who were operated on between March 1998 and August 2000 and randomized to off-pump or on-pump coronary bypass surgery, will be invited for an additional assessment of their cognitive and clinical status and quality of life, five years after surgery. Patients will undergo a battery of ten neuropsychologic tests to determine their cognitive status. Clinical status will be assessed by an interview. Questionnaires will be used to measure quality of life.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
Netherlands | |
University Medical Center, Department of Anesthesiology | |
Utrecht, Netherlands, 3584 CX |
Study Director: | Cor J Kalkman, MD, PhD | UMC Utrecht, The Netherlands |
Study ID Numbers: | WOM protocol 98/009-O |
Study First Received: | September 13, 2005 |
Last Updated: | December 3, 2007 |
ClinicalTrials.gov Identifier: | NCT00189215 History of Changes |
Health Authority: | Netherlands: Medical Ethics Review Committee (METC) |
coronary artery disease cardiopulmonary bypass cognition disorders |
Arterial Occlusive Diseases Heart Diseases Myocardial Ischemia Vascular Diseases Ischemia Arteriosclerosis Cognition Disorders |
Coronary Disease Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Dementia Coronary Artery Disease Delirium |
Arterial Occlusive Diseases Coronary Disease Heart Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Myocardial Ischemia |
Vascular Diseases Cardiovascular Diseases Arteriosclerosis Coronary Artery Disease Cognition Disorders |