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

May 29, 2009 updated by: Ottawa Hospital Research Institute

Does Apolipoprotein E Genotype Predict Delirium and Postoperative Cognitive Dysfunction?

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).

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1Y 4E9
        • The Ottawa Hospital - Civic Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients 60 years of age or greater undergoing open repair of the abdominal aorta at an academic tertiary care hospital.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Open Aortic Repair
Patients 60 years of age and older undergoing open repair of the abdominal aorta

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Delirium as assessed by the Confusion Assessment Method
Time Frame: 7 days postoperatively
7 days postoperatively

Secondary Outcome Measures

Outcome Measure
Time Frame
POCD as assessed by a battery of 9 neuropsychometric tests
Time Frame: 7 days postoperatively
7 days postoperatively
POCD as assessed by a battery of 9 neuropsychometric tests
Time Frame: 3 months postoperatively
3 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ottawa Hospital Research Institute

Collaborators

University of Ottawa
Canadian Anesthesiologists' Society

Investigators

  • Principal Investigator: Gregory L Bryson, MD, FRCPC, Department of Anesthesiology, The Ottawa Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

May 29, 2009

First Submitted That Met QC Criteria

May 29, 2009

First Posted (Estimate)

June 2, 2009

Study Record Updates

Last Update Posted (Estimate)

June 2, 2009

Last Update Submitted That Met QC Criteria

May 29, 2009

Last Verified

May 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OHREB 2004800-01H

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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