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, Belfast Health and Social Care Trust
Trial 8
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| 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 |
| NCT number | NCT02299037 | ClinicalTrials.gov |
| Status | Unknown | ClinicalTrials.gov |
| Enrollment | 316 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Belfast Health and Social Care Trust | ClinicalTrials.gov |
| Conditions | Delirium | ClinicalTrials.gov |
| First posted | 2014-11-24 | ClinicalTrials.gov |
| Last updated | 2023-12-26 | ClinicalTrials.gov |
Registered outcomes 18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Incidence of inpatient post-operative delirium as measured using the confusion assessment method (CAM) | Day 1 post-operatively | ClinicalTrials.gov | |
| Primary | Incidence of inpatient post-operative delirium as measured using the confusion assessment method (CAM) | Day 2 post-operatively | ClinicalTrials.gov | |
| Primary | Incidence of inpatient post-operative delirium as measured using the confusion assessment method (CAM) | Day 3 post-operatively | ClinicalTrials.gov | |
| Primary | Performance on the Mini-Mental Status Examination (MMSE; Folstein MF, Folstein SE et al. 1975). | 8 year follow-up | A 30 point scale pre-operatively and at follow-up 7-8 years later. | ClinicalTrials.gov |
| Primary | Performance on the Executive Clock Drawing Task (CLOX 1 & 2; Royall, Cordes et al. 1998). | 8 year follow-up | A 24 point scale pre-operatively and at follow-up 7-8 years later. | ClinicalTrials.gov |
| Primary | Performance on the Controlled Oral Word Association Test (COWAT; Benton, A.L. Hamsher, K. Sivan, A.B. 1983). | 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. | ClinicalTrials.gov |
| Primary | Performance on the Stroop Colour and Word Test (Golden 1978). | 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. | ClinicalTrials.gov |
| Primary | Colour Trails 1&2 (D'Elia, Satz et al. 1996). | 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. | ClinicalTrials.gov |
| Primary | New York Paragraph Recall Test (Kluger, Ferris et al. 1999). | 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. | ClinicalTrials.gov |
| Primary | Weighted Composite Summary Cognitive Measure at 7-8 year Follow-up | 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)). | ClinicalTrials.gov |
| Secondary | Performance on the Mini-Mental Status Examination (MMSE; Folstein MF, Folstein SE et al. 1975). | 6-12 weeks post-surgery | Performance on this 30 point scale pre-operatively and at follow-up 6-12 weeks later will be compared. | ClinicalTrials.gov |
| Secondary | Performance on the Executive Clock Drawing Task (CLOX 1 & 2; Royall, Cordes et al. 1998). | 6-12 weeks post-surgery | Performance on this 24 point scale pre-operatively and at follow-up 6-12 weeks later will be compared. | ClinicalTrials.gov |
| Secondary | Performance on the Controlled Oral Word Association Test (COWAT; Benton, A.L. Hamsher, K. Sivan, A.B. 1983). | 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. | ClinicalTrials.gov |
| Secondary | Performance on the Stroop Colour and Word Test (Golden 1978). | 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. | ClinicalTrials.gov |
| Secondary | Colour Trails 1&2 (D'Elia, Satz et al. 1996). | 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. | ClinicalTrials.gov |
| Secondary | New York Paragraph Recall Test (Kluger, Ferris et al. 1999). | 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. | ClinicalTrials.gov |
| Secondary | Weighted Composite Summary Cognitive Measure at 6-12 Week Follow-Up | 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)). | ClinicalTrials.gov |
| Secondary | Incidence of mild cognitive impairment and dementia at the time of follow-up study visit | 8 year follow-up | Diagnosed using appropriate criteria (Albert, DeKosky et al., 2011, McKhann, Knopman et al., 2011). | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 4
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Category Fluency | Primary outcome | ConductCognition |
| Clock Drawing Task | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Verbal Fluency | Primary outcome | ConductCognition |
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.3.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 4a570df2e7274cee2d4fa2959402fab41880e2cd412e4b590390035fbea69391 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
Release trials-2026-11-12-0.3.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.