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

This study has been completed.
Sponsor:
Collaborators:
Canadian Anesthesiologists' Society
University of Ottawa
Information provided by:
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT00911677
First received: May 29, 2009
Last updated: NA
Last verified: May 2009
History: No changes posted
  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:

MedlinePlus related topics: Delirium
U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

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

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

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Ottawa Hospital Research Institute

Additional 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
Study First Received: May 29, 2009
Last Updated: May 29, 2009
Health Authority: Canada: Ethics Review Committee

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
Cognition Disorders
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
 Nervous System Diseases
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 21, 2013