Delirium Clinical Trial
Official title:
Does Apolipoprotein E Genotype Predict Delirium and Postoperative Cognitive Dysfunction?
Verified date | May 2009 |
Source | Ottawa Hospital Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Ethics Review Committee |
Study type | Observational |
Patients with the APOE-ε4 genotype are at increased risk of both vascular dementia and peripheral vascular disease. Patients undergoing major vascular surgery are at particularly high risk of delirium and other, more subtle, changes in cognitive function following surgery. The hypothesis of this trial is that the APOE-ε4 genotype is associated with both delirium and postoperative cognitive dysfunction (POCD).
Status | Completed |
Enrollment | 100 |
Est. completion date | May 2009 |
Est. primary completion date | March 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 60 Years and older |
Eligibility |
Inclusion Criteria: - Age 60 or greater - Open repair of the abdominal aorta Exclusion Criteria: - refusal; - planned endovascular repair; - emergency surgery; - previous diagnosis of dementia, Parkinson's disease, or psychiatric illness; - active alcohol or substance abuse; and - physical inability to complete neuropsychometric testing. |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Canada | The Ottawa Hospital - Civic Campus | Ottawa | Ontario |
Lead Sponsor | Collaborator |
---|---|
Ottawa Hospital Research Institute | Canadian Anesthesiologists' Society, University of Ottawa |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Delirium as assessed by the Confusion Assessment Method | 7 days postoperatively | Yes | |
Secondary | POCD as assessed by a battery of 9 neuropsychometric tests | 7 days postoperatively | Yes | |
Secondary | POCD as assessed by a battery of 9 neuropsychometric tests | 3 months postoperatively | Yes |
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