- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02299037
Predicting the Risk of Post-operative Delirium: Use of Neuropsychology, Serum and CSF Biomarkers and Genetics to Predict Risk of Post-operative Delirium
December 20, 2023 updated by: Dr Emma Cunningham, Belfast Health and Social Care Trust
The purpose of the study is to determine if pre-operative neuropsychological characteristics, apolipoprotein E4 status and/or cerebrospinal fluid (CSF) and serum biomarkers can predict those most at risk of post-operative delirium.
Patients over the age of 65 years undergoing elective primary hip or knee arthroplasty in Musgrave Park Hospital are invited to take part.
Participants undergo a pre-operative neuropsychological assessment which is repeated 6-12 weeks post-operatively at the time of surgical review appointment.
At the time of surgery advantage is taken of the necessary venous cannulation and spinal anaesthetic to gain venous blood and CSF samples respectively.
Venous blood is also sampled post-operatively.
Patients are assessed daily for delirium, using the Confusion Assessment Method, until discharge.
The association between delirium and subsequent cognitive decline is now well established in the literature.
It is not yet clear whether this is solely because delirium following elective surgery indicates a previously unrecognised neurodegenerative process or whether the delirium itself exerts an additional pathophysiological insult.
In order to investigate this, a follow-up study of these participants, approximately 8 years later is currently being conducted.
Neuropsychological assessment and venous blood sampling will be repeated with consenting participants.
Furthermore, the significance of subtle symptoms, not sufficient to fulfil the criteria for delirium and known as subsyndromal delirium, in relation to cognitive function years later will be analysed.
Study Overview
Status
Active, not recruiting
Conditions
Study Type
Observational
Enrollment (Estimated)
316
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
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Belfast, United Kingdom, BT12 6BA
- Centre for Public Health, Queen's University Belfast
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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
65 years and older (Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Patients 65 years of age or more undergoing primary, elective hip and knee arthroplasty in a single surgical unit.
Description
Inclusion Criteria:
- living at home
- undergoing primary, elective hip or knee arthroplasty
- spinal anaesthetic with intrathecal diamorphine anticipated
Exclusion Criteria:
- neurological, hearing or visual disability affecting ability to participate in study
- known neurodegenerative condition eg dementia, Parkinson's disease, multiple sclerosis
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of inpatient post-operative delirium as measured using the confusion assessment method (CAM)
Time Frame: Day 1 post-operatively
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Day 1 post-operatively
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Incidence of inpatient post-operative delirium as measured using the confusion assessment method (CAM)
Time Frame: Day 2 post-operatively
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Day 2 post-operatively
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Incidence of inpatient post-operative delirium as measured using the confusion assessment method (CAM)
Time Frame: Day 3 post-operatively
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Day 3 post-operatively
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Performance on the Mini-Mental Status Examination (MMSE; Folstein MF, Folstein SE et al. 1975).
Time Frame: 8 year follow-up
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A 30 point scale pre-operatively and at follow-up 7-8 years later.
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8 year follow-up
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Performance on the Executive Clock Drawing Task (CLOX 1 & 2; Royall, Cordes et al. 1998).
Time Frame: 8 year follow-up
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A 24 point scale pre-operatively and at follow-up 7-8 years later.
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8 year follow-up
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Performance on the Controlled Oral Word Association Test (COWAT; Benton, A.L. Hamsher, K. Sivan, A.B. 1983).
Time Frame: 8 year follow-up
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A test which measures both phonemic and semantic fluency.
One point is awarded for each word generated (within the task parameters) within one minute.
A total of five categories are assessed.
Performance pre-operatively and at follow-up 7-8 years later will be compared.
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8 year follow-up
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Performance on the Stroop Colour and Word Test (Golden 1978).
Time Frame: 8 year follow-up
|
This test features 100 items, the score reflects how many words were correctly identified in 45 seconds.
A total of five categories are assessed.
Performance pre-operatively and at follow-up 7-8 years later will be compared.
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8 year follow-up
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Colour Trails 1&2 (D'Elia, Satz et al. 1996).
Time Frame: 8 year follow-up
|
Performance is measured in the time taken (seconds) taken to successfully complete this test.
Performance pre-operatively and at follow-up 7-8 years later will be compared.
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8 year follow-up
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New York Paragraph Recall Test (Kluger, Ferris et al. 1999).
Time Frame: 8 year follow-up
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This test is scored based on the number of correctly recalled sections of the story.
There are two recall conditions - immediate recall, assessed immediately following the reading of the paragraph and delayed recall, performance assessed five minutes following conclusion of the story.
Each condition can earn a maximum of 21 points.
Performance pre-operatively and at follow-up 7-8 years later will be compared.
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8 year follow-up
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Weighted Composite Summary Cognitive Measure at 7-8 year Follow-up
Time Frame: 8 year follow-up
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This weighted composite summary cognitive measure will be calculated based on the work of Inouye et al (Inouye, Marcantonio et al. 2016).
This will be calculated (using outcome measures 4-9 above), for two time points 1) using preoperative scores and 2) using follow-up study visit scores.
With the follow-up study visit scores being our primary outcome measure.
The cognitive tests used in this study are similar to those utilised by the General Cognitive Performance score (Jones, Rudolph et al. 2010) and in deriving these scores we intend to use locally available normative data from representative samples, namely the Irish longitudinal studies (The Northern Ireland Cohort for the Longitudinal Study of Ageing (NICOLA) and The Irish Longitudinal Study on Ageing (TILDA)).
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8 year follow-up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Performance on the Mini-Mental Status Examination (MMSE; Folstein MF, Folstein SE et al. 1975).
Time Frame: 6-12 weeks post-surgery
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Performance on this 30 point scale pre-operatively and at follow-up 6-12 weeks later will be compared.
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6-12 weeks post-surgery
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Performance on the Executive Clock Drawing Task (CLOX 1 & 2; Royall, Cordes et al. 1998).
Time Frame: 6-12 weeks post-surgery
|
Performance on this 24 point scale pre-operatively and at follow-up 6-12 weeks later will be compared.
|
6-12 weeks post-surgery
|
Performance on the Controlled Oral Word Association Test (COWAT; Benton, A.L. Hamsher, K. Sivan, A.B. 1983).
Time Frame: 6-12 weeks post-surgery
|
A test which measures both phonemic and semantic fluency.
One point is awarded for each word generated (within the task parameters) within one minute.
A total of five categories are assessed.
Performance pre-operatively and at follow-up 6-12 weeks later will be compared.
|
6-12 weeks post-surgery
|
Performance on the Stroop Colour and Word Test (Golden 1978).
Time Frame: 6-12 weeks post-surgery
|
This test features 100 items, the score reflects how many words were correctly identified in 45 seconds.
A total of five categories are assessed.
Performance pre-operatively and at follow-up 6-12 weeks later will be compared.
|
6-12 weeks post-surgery
|
Colour Trails 1&2 (D'Elia, Satz et al. 1996).
Time Frame: 6-12 weeks post-surgery
|
Performance is measured in the time taken (seconds) taken to successfully complete this test.
Performance pre-operatively and at follow-up 6-12 weeks later will be compared.
|
6-12 weeks post-surgery
|
New York Paragraph Recall Test (Kluger, Ferris et al. 1999).
Time Frame: 6-12 weeks post-surgery
|
This test is scored based on the number of correctly recalled sections of the story.
There are two recall conditions - immediate recall, assessed immediately following the reading of the paragraph and delayed recall, performance assessed five minutes following conclusion of the story.
Each condition can earn a maximum of 21 points.
Performance pre-operatively and at follow-up 6-12 weeks later will be compared.
|
6-12 weeks post-surgery
|
Weighted Composite Summary Cognitive Measure at 6-12 Week Follow-Up
Time Frame: 6-12 weeks post-surgery
|
This weighted composite summary cognitive measure will be calculated based on the work of Inouye et al (Inouye, Marcantonio et al. 2016).
This will be calculated (using outcome measures 11-16 above), for two time points 1) using preoperative scores and 2) using follow-up study visit scores at 6-12 weeks post-operatively.
With the follow-up study visit scores being our primary outcome measure.
The cognitive tests used in this study are similar to those utilised by the General Cognitive Performance score (Jones, Rudolph et al. 2010) and in deriving these scores we intend to use locally available normative data from representative samples, namely the Irish longitudinal studies (The Northern Ireland Cohort for the Longitudinal Study of Ageing (NICOLA) and The Irish Longitudinal Study on Ageing (TILDA)).
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6-12 weeks post-surgery
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Incidence of mild cognitive impairment and dementia at the time of follow-up study visit
Time Frame: 8 year follow-up
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Diagnosed using appropriate criteria (Albert, DeKosky et al., 2011, McKhann, Knopman et al., 2011).
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8 year follow-up
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
March 1, 2012
Primary Completion (Actual)
February 1, 2015
Study Completion (Estimated)
February 1, 2025
Study Registration Dates
First Submitted
October 31, 2014
First Submitted That Met QC Criteria
November 20, 2014
First Posted (Estimated)
November 24, 2014
Study Record Updates
Last Update Posted (Actual)
December 26, 2023
Last Update Submitted That Met QC Criteria
December 20, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09069PP-OPMS
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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