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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00911677
First Posted: June 2, 2009
Last Update Posted: June 2, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Canadian Anesthesiologists' Society
University of Ottawa
Information provided by:
Ottawa Hospital Research Institute
  Purpose
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).

Condition
Delirium Postoperative Cognitive Dysfunction

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Does Apolipoprotein E Genotype Predict Delirium and Postoperative Cognitive Dysfunction?

Resource links provided by NLM:


Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:
  • Delirium as assessed by the Confusion Assessment Method [ Time Frame: 7 days postoperatively ]

Secondary Outcome Measures:
  • POCD as assessed by a battery of 9 neuropsychometric tests [ Time Frame: 7 days postoperatively ]
  • POCD as assessed by a battery of 9 neuropsychometric tests [ Time Frame: 3 months postoperatively ]

Enrollment: 100
Study Start Date: August 2005
Study Completion Date: May 2009
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
Open Aortic Repair
Patients 60 years of age and older undergoing open repair of the abdominal aorta

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00911677


Locations
Canada, Ontario
The Ottawa Hospital - Civic Campus
Ottawa, Ontario, Canada, K1Y 4E9
Sponsors and Collaborators
Ottawa Hospital Research Institute
Canadian Anesthesiologists' Society
University of Ottawa
Investigators
Principal Investigator: Gregory L Bryson, MD, FRCPC Department of Anesthesiology, The Ottawa Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gregory L Bryson, Department of Anesthesiology, The Ottawa Hospital
ClinicalTrials.gov Identifier: NCT00911677     History of Changes
Other Study ID Numbers: OHREB 2004800-01H
First Submitted: May 29, 2009
First Posted: June 2, 2009
Last Update Posted: June 2, 2009
Last Verified: May 2009

Keywords provided by Ottawa Hospital Research Institute:
Delirium (MeSH Unique ID D003693)
Cognition Disorders (MeSH Unique ID D003072)
Postoperative Complications (MeSH Unique ID D011183)
Apolipoproteins E (MeSH Unique ID D001057)

Additional relevant MeSH terms:
Delirium
Cognitive Dysfunction
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Cognition Disorders