DeliriumNCT02299037
Predicting the Risk of Post-operative Delirium: Use of Neuropsychology, Serum and CSF Biomarkers and Genetics to Predict Risk of Post-operative Delirium
An observational study of Delirium, run by Belfast Health and Social Care Trust at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Delirium
- How many people
- 316 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2012to Feb 2025
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Patients 65 years of age or more undergoing primary, elective hip and knee arthroplasty in a single surgical unit.
Who may be able to join
- living at home
- undergoing primary, elective hip or knee arthroplasty
- spinal anaesthetic with intrathecal diamorphine anticipated
Who cannot join
- neurological, hearing or visual disability affecting ability to participate in study
- known neurodegenerative condition eg dementia, Parkinson's disease, multiple sclerosis
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Centre for Public Health, Queen's University Belfast
Belfast, BT12 6BA
About this study
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.
- Conditions
- Delirium
- Medical subject headings
- Delirium
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of inpatient post-operative delirium as measured using the confusion assessment method (CAM)
Measured: Day 1 post-operatively
Incidence of inpatient post-operative delirium as measured using the confusion assessment method (CAM)
Measured: Day 2 post-operatively
Incidence of inpatient post-operative delirium as measured using the confusion assessment method (CAM)
Measured: Day 3 post-operatively
Performance on the Mini-Mental Status Examination (MMSE; Folstein MF, Folstein SE et al. 1975).
A 30 point scale pre-operatively and at follow-up 7-8 years later.
Measured: 8 year follow-up
Performance on the Executive Clock Drawing Task (CLOX 1 & 2; Royall, Cordes et al. 1998).
A 24 point scale pre-operatively and at follow-up 7-8 years later.
Measured: 8 year follow-up
Performance on the Controlled Oral Word Association Test (COWAT; Benton, A.L. Hamsher, K. Sivan, A.B. 1983).
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.
Measured: 8 year follow-up
Performance on the Stroop Colour and Word Test (Golden 1978).
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.
Measured: 8 year follow-up
Colour Trails 1&2 (D'Elia, Satz et al. 1996).
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.
Measured: 8 year follow-up
New York Paragraph Recall Test (Kluger, Ferris et al. 1999).
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.
Measured: 8 year follow-up
Weighted Composite Summary Cognitive Measure at 7-8 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)).
Measured: 8 year follow-up
Secondary outcomes (8)
Performance on the Mini-Mental Status Examination (MMSE; Folstein MF, Folstein SE et al. 1975).
Performance on this 30 point scale pre-operatively and at follow-up 6-12 weeks later will be compared.
Measured: 6-12 weeks post-surgery
Performance on the Executive Clock Drawing Task (CLOX 1 & 2; Royall, Cordes et al. 1998).
Performance on this 24 point scale pre-operatively and at follow-up 6-12 weeks later will be compared.
Measured: 6-12 weeks post-surgery
Performance on the Controlled Oral Word Association Test (COWAT; Benton, A.L. Hamsher, K. Sivan, A.B. 1983).
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.
Measured: 6-12 weeks post-surgery
Performance on the Stroop Colour and Word Test (Golden 1978).
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.
Measured: 6-12 weeks post-surgery
Colour Trails 1&2 (D'Elia, Satz et al. 1996).
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.
Measured: 6-12 weeks post-surgery
New York Paragraph Recall Test (Kluger, Ferris et al. 1999).
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.
Measured: 6-12 weeks post-surgery
Weighted Composite Summary Cognitive Measure at 6-12 Week 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 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)).
Measured: 6-12 weeks post-surgery
Incidence of mild cognitive impairment and dementia at the time of follow-up study visit
Diagnosed using appropriate criteria (Albert, DeKosky et al., 2011, McKhann, Knopman et al., 2011).
Measured: 8 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2014 (estimated)
- Study startMar 2012
- Primary completionFeb 2015
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 316 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Belfast Health and Social Care Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Emma Cunningham, Belfast Health and Social Care Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02299037
- Sponsor's protocol ID
- 09069PP-OPMS
- Status last verified
- Dec 2023
- First submitted
- 31 Oct 2014
- Last updated
- 26 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting the Risk of Post-operative Delirium: Use of Neuropsychology, Serum and CSF Biomarkers and Genetics to Predict Risk of Post-operative Delirium
- ClinicalTrials.gov ID
- NCT02299037
- Acronym / sponsor ID
- 09069PP-OPMS
- Conditions
- Delirium
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 316 participants (estimated)
- Lead sponsor
- Belfast Health and Social Care TrustUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2025 (estimated)
- First posted
- 24 Nov 2014 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Patients 65 years of age or more undergoing primary, elective hip and knee arthroplasty in a single surgical unit.
Key inclusion criteria (3 listed)
- living at home
- undergoing primary, elective hip or knee arthroplasty
- spinal anaesthetic with intrathecal diamorphine anticipated
Key exclusion criteria (2 listed)
- neurological, hearing or visual disability affecting ability to participate in study
- known neurodegenerative condition eg dementia, Parkinson's disease, multiple sclerosis
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
Incidence of inpatient post-operative delirium as measured using the confusion assessment method (CAM)
Time frame: Day 1 post-operatively
Incidence of inpatient post-operative delirium as measured using the confusion assessment method (CAM)
Time frame: Day 2 post-operatively
Incidence of inpatient post-operative delirium as measured using the confusion assessment method (CAM)
Time frame: 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.
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.
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.
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.
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.
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.
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 secondary outcomes
Performance on the Mini-Mental Status Examination (MMSE; Folstein MF, Folstein SE et al. 1975).
Time frame: 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 the Controlled Oral Word Association Test (COWAT; Benton, A.L. Hamsher, K. Sivan, A.B. 1983).
Time frame: 6-12 weeks post-surgery
Performance on the Stroop Colour and Word Test (Golden 1978).
Time frame: 6-12 weeks post-surgery
Colour Trails 1&2 (D'Elia, Satz et al. 1996).
Time frame: 6-12 weeks post-surgery
New York Paragraph Recall Test (Kluger, Ferris et al. 1999).
Time frame: 6-12 weeks post-surgery
Weighted Composite Summary Cognitive Measure at 6-12 Week Follow-Up
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, run by Belfast Health and Social Care Trust at 1 site in United Kingdom.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 26 Dec 2023. 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 United Kingdom. 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?
Results are not available in the source record.
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?
Incidence of inpatient post-operative delirium as measured using the confusion assessment method (CAM) (time frame: Day 1 post-operatively). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Dec 2023.