Does APOE-e4 Predict Delirium and Cognitive Dysfunction After Surgery?

Delirium Clinical Trial

Official title:

Does Apolipoprotein E Genotype Predict Delirium and Postoperative Cognitive Dysfunction?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00911677
• Other study ID #: OHREB 2004800-01H
• Status: Completed
• Phase: N/A
• First received: May 29, 2009
• Last updated: May 29, 2009
• Start date: August 2005
• Est. completion date: May 2009

Study information

• 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

Clinical Trial Summary

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).

Recruitment information / eligibility

• 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cognition Disorders
• Delirium
• Postoperative Cognitive Dysfunction

Locations

Country	Name	City	State
Canada	The Ottawa Hospital - Civic Campus	Ottawa	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute	Canadian Anesthesiologists' Society, University of Ottawa

Country where clinical trial is conducted

Canada, 

Outcome

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