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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Delirium
Lead sponsor: Belfast Health and Social Care Trust
Sponsor class: OTHER
First posted: 2014-11-24
Enrollment: 316
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of inpatient post-operative delirium as measured using the confusion assessment method (CAM)
timeFrame: Day 1 post-operatively
measure: Incidence of inpatient post-operative delirium as measured using the confusion assessment method (CAM)
timeFrame: Day 2 post-operatively
measure: Incidence of inpatient post-operative delirium as measured using the confusion assessment method (CAM)
timeFrame: Day 3 post-operatively
measure: Performance on the Mini-Mental Status Examination (MMSE; Folstein MF, Folstein SE et al. 1975).
timeFrame: 8 year follow-up
measure: Performance on the Executive Clock Drawing Task (CLOX 1 & 2; Royall, Cordes et al. 1998).
timeFrame: 8 year follow-up
measure: Performance on the Controlled Oral Word Association Test (COWAT; Benton, A.L. Hamsher, K. Sivan, A.B. 1983).
timeFrame: 8 year follow-up
measure: Performance on the Stroop Colour and Word Test (Golden 1978).
timeFrame: 8 year follow-up
measure: Colour Trails 1&2 (D'Elia, Satz et al. 1996).
timeFrame: 8 year follow-up
measure: New York Paragraph Recall Test (Kluger, Ferris et al. 1999).
timeFrame: 8 year follow-up
measure: Weighted Composite Summary Cognitive Measure at 7-8 year Follow-up
timeFrame: 8 year follow-up
Secondary outcomes:
measure: Performance on the Mini-Mental Status Examination (MMSE; Folstein MF, Folstein SE et al. 1975).
timeFrame: 6-12 weeks post-surgery
measure: Performance on the Executive Clock Drawing Task (CLOX 1 & 2; Royall, Cordes et al. 1998).
timeFrame: 6-12 weeks post-surgery
measure: Performance on the Controlled Oral Word Association Test (COWAT; Benton, A.L. Hamsher, K. Sivan, A.B. 1983).
timeFrame: 6-12 weeks post-surgery
measure: Performance on the Stroop Colour and Word Test (Golden 1978).
timeFrame: 6-12 weeks post-surgery
measure: Colour Trails 1&2 (D'Elia, Satz et al. 1996).
timeFrame: 6-12 weeks post-surgery
measure: New York Paragraph Recall Test (Kluger, Ferris et al. 1999).
timeFrame: 6-12 weeks post-surgery
measure: Weighted Composite Summary Cognitive Measure at 6-12 Week Follow-Up
timeFrame: 6-12 weeks post-surgery
measure: Incidence of mild cognitive impairment and dementia at the time of follow-up study visit
timeFrame: 8 year follow-up
Other outcomes:
Locations:
city: Belfast
country: United Kingdom
facility: Centre for Public Health, Queen's University Belfast
Study officials:
References: