DeliriumNCT00911677
Does APOE-e4 Predict Delirium and Cognitive Dysfunction After Surgery?
An observational study of Delirium and Postoperative Cognitive Dysfunction, run by Ottawa Hospital Research Institute at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Delirium, Postoperative Cognitive Dysfunction
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2005to May 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients 60 years of age or greater undergoing open repair of the abdominal aorta at an academic tertiary care hospital.
Who may be able to join
- Age 60 or greater
- Open repair of the abdominal aorta
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
- Conditions
- Delirium, Postoperative Cognitive Dysfunction
- Keywords
- Delirium (MeSH Unique ID D003693), Cognition Disorders (MeSH Unique ID D003072), Postoperative Complications (MeSH Unique ID D011183), Apolipoproteins E (MeSH Unique ID D001057)
- Medical subject headings
- Delirium, Postoperative Cognitive Complications, Cognition Disorders, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Open Aortic Repair | Patients 60 years of age and older undergoing open repair of the abdominal aorta |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delirium as assessed by the Confusion Assessment Method
Measured: 7 days postoperatively
Secondary outcomes (2)
POCD as assessed by a battery of 9 neuropsychometric tests
Measured: 7 days postoperatively
POCD as assessed by a battery of 9 neuropsychometric tests
Measured: 3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2009 (estimated)
- Study startAug 2005
- Primary completionMar 2008
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Anesthesiologists' Society, University of Ottawa
- Investigators
- Gregory L Bryson, MD, FRCPC, Principal investigator, Department of Anesthesiology, The Ottawa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00911677
- Sponsor's protocol ID
- OHREB 2004800-01H
- Status last verified
- May 2009
- First submitted
- 29 May 2009
- Last updated
- 2 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Bryson GL, Wyand A, Wozny D, Rees L, Taljaard M, Nathan H. A prospective cohort study evaluating associations among delirium, postoperative cognitive dysfunction, and apolipoprotein E genotype following open aortic repair. Can J Anaesth. 2011 Mar;58(3):246-55. doi: 10.1007/s12630-010-9446-6. Epub 2011 Jan 11.
PubMed 21222188Bryson GL, Wyand A, Wozny D, Rees L, Taljaard M, Nathan H. The clock drawing test is a poor screening tool for postoperative delirium and cognitive dysfunction after aortic repair. Can J Anaesth. 2011 Mar;58(3):267-74. doi: 10.1007/s12630-010-9448-4. Epub 2010 Dec 31.
PubMed 21194015
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Apolipoprotein E Genotype Predict Delirium and Postoperative Cognitive Dysfunction?
- ClinicalTrials.gov ID
- NCT00911677
- Acronym / sponsor ID
- OHREB 2004800-01H
- Conditions
- Delirium, Postoperative Cognitive Dysfunction
- Keywords
- Delirium (MeSH Unique ID D003693), Cognition Disorders (MeSH Unique ID D003072), Postoperative Complications (MeSH Unique ID D011183), Apolipoproteins E (MeSH Unique ID D001057)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Canadian Anesthesiologists' Society, University of Ottawa
- Study start
- Aug 2005
- Primary completion
- Mar 2008 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 2 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open Aortic Repair | – | –Patients 60 years of age and older undergoing open repair of the abdominal aorta |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients 60 years of age or greater undergoing open repair of the abdominal aorta at an academic tertiary care hospital.
Key inclusion criteria (2 listed)
- Age 60 or greater
- Open repair of the abdominal aorta
Key exclusion criteria (6 listed)
- refusal;
- planned endovascular repair;
- emergency surgery;
- previous diagnosis of dementia, Parkinson's disease, or psychiatric illness;
- active alcohol or substance abuse; and
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Delirium as assessed by the Confusion Assessment Method
Time frame: 7 days postoperatively
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2009.
- Derived from this study: PubMed 21222188Bryson GL, Wyand A, Wozny D, Rees L, Taljaard M, Nathan H. A prospective cohort study evaluating associations among delirium, postoperative cognitive dysfunction, and apolipoprotein E genotype following open aortic repair. Can J Anaesth. 2011 Mar;58(3):246-55. doi: 10.1007/s12630-010-9446-6. Epub 2011 Jan 11.
- Derived from this study: PubMed 21194015Bryson GL, Wyand A, Wozny D, Rees L, Taljaard M, Nathan H. The clock drawing test is a poor screening tool for postoperative delirium and cognitive dysfunction after aortic repair. Can J Anaesth. 2011 Mar;58(3):267-74. doi: 10.1007/s12630-010-9448-4. Epub 2010 Dec 31.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory L Bryson, MD, FRCPC principal investigator
Department of Anesthesiology, The Ottawa Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium and Postoperative Cognitive Dysfunction, run by Ottawa Hospital Research Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delirium as assessed by the Confusion Assessment Method (time frame: 7 days postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00911677, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2009.