Predicting the Risk of Post-operative Delirium: Use of Neuropsychology, Serum and CSF Biomarkers and Genetics to Predict Risk of Post-operative Delirium

NCT02299037 | Unknown

• 1 other identifier: 09069PP-OPMS
• Study Type: observational
• Target: 316
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (10)

• Incidence of inpatient post-operative delirium as measured using the confusion assessment method (CAM)

  Day 1 post-operatively

• Incidence of inpatient post-operative delirium as measured using the confusion assessment method (CAM)

  Day 2 post-operatively

• Incidence of inpatient post-operative delirium as measured using the confusion assessment method (CAM)

  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.

  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.

  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.

  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.

  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.

  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.

  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)).

  8 year follow-up

Secondary Outcomes (8)

• Performance on the Mini-Mental Status Examination (MMSE; Folstein MF, Folstein SE et al. 1975).

  6-12 weeks post-surgery

• Performance on the Executive Clock Drawing Task (CLOX 1 & 2; Royall, Cordes et al. 1998).

  6-12 weeks post-surgery

• Performance on the Controlled Oral Word Association Test (COWAT; Benton, A.L. Hamsher, K. Sivan, A.B. 1983).

  6-12 weeks post-surgery

• Performance on the Stroop Colour and Word Test (Golden 1978).

  6-12 weeks post-surgery

• Colour Trails 1&2 (D'Elia, Satz et al. 1996).

  6-12 weeks post-surgery

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• living at home
• undergoing primary, elective hip or knee arthroplasty
• spinal anaesthetic with intrathecal diamorphine anticipated

You may not qualify if:

• neurological, hearing or visual disability affecting ability to participate in study
• known neurodegenerative condition eg dementia, Parkinson's disease, multiple sclerosis

Sponsors & Collaborators

• Belfast Health and Social Care Trust: lead

Study Sites (1)

Centre for Public Health, Queen's University Belfast

Belfast, BT12 6BA, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

serum cerebrospinal fluid DNA extracted from blood

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Lecturer Geriatric Medicine

Study Record Dates

• First Submitted: October 31, 2014
• First Posted: November 24, 2014
• Study Start: March 1, 2012
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2025
• Last Updated: December 26, 2023

Record last verified: 2023-12

Locations

GB (1)