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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • United Kingdom
      • Belfast, United Kingdom, BT12 6BA
        • Centre for Public Health, Queen's University Belfast

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
Day 1 post-operatively
Incidence of inpatient post-operative delirium as measured using the confusion assessment method (CAM)
Time Frame: Day 2 post-operatively
Day 2 post-operatively
Incidence of inpatient post-operative delirium as measured using the confusion assessment method (CAM)
Time Frame: Day 3 post-operatively
Day 3 post-operatively
Performance on the Mini-Mental Status Examination (MMSE; Folstein MF, Folstein SE et al. 1975).
Time Frame: 8 year follow-up
A 30 point scale pre-operatively and at follow-up 7-8 years later.
8 year follow-up
Performance on the Executive Clock Drawing Task (CLOX 1 & 2; Royall, Cordes et al. 1998).
Time Frame: 8 year follow-up
A 24 point scale pre-operatively and at follow-up 7-8 years later.
8 year follow-up
Performance on the Controlled Oral Word Association Test (COWAT; Benton, A.L. Hamsher, K. Sivan, A.B. 1983).
Time Frame: 8 year follow-up
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.
8 year follow-up
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.
8 year follow-up
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.
8 year follow-up
New York Paragraph Recall Test (Kluger, Ferris et al. 1999).
Time Frame: 8 year follow-up
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.
8 year follow-up
Weighted Composite Summary Cognitive Measure at 7-8 year Follow-up
Time Frame: 8 year follow-up
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)).
8 year follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
Performance on this 30 point scale pre-operatively and at follow-up 6-12 weeks later will be compared.
6-12 weeks post-surgery
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)).
6-12 weeks post-surgery
Incidence of mild cognitive impairment and dementia at the time of follow-up study visit
Time Frame: 8 year follow-up
Diagnosed using appropriate criteria (Albert, DeKosky et al., 2011, McKhann, Knopman et al., 2011).
8 year follow-up

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Belfast Health and Social Care Trust

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2015

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 31, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2014

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 24, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 26, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 20, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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