Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001070527
Ethics application status
Approved
Date submitted
8/04/2015
Date registered
13/10/2015
Date last updated
19/02/2020
Date data sharing statement initially provided
19/02/2020
Date results provided
19/02/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Assessment and review of cognition, Alzheimer's disease and inflammation after hospital intervention
Scientific title
Assessment and review of cognition, Alzheimer's disease and inflammation in elderly patients after hospital intervention (The ARCADIAN Study).
Secondary ID [1] 286490 0
None
Universal Trial Number (UTN)
Trial acronym
ARCADIAN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer's disease 294697 0
Dementia 294698 0
Inflammation 294699 0
Condition category
Condition code
Neurological 294990 294990 0 0
Dementias
Anaesthesiology 294991 294991 0 0
Anaesthetics
Surgery 294992 294992 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Observation study of elderly patients (60 years and older) undergoing healthcare interventions requiring surgery and anaesthesia. Patients will undergo baseline and 3 month neuropsychological testing prior to and following surgery. The two neuropsychological tests take roughly one hour and are completed at the patient's home. During the hospital stay patients will have blood samples taken prior to anaesthetic induction, at 30 minutes post surgical incision and also at 6, 24 and 48 hours following surgery. Blood samples will be analysed for inflammatory markers.
Intervention code [1] 291585 0
Not applicable
Comparator / control treatment
Control data will be obtained from a parallel non-surgical group recruited previously for a related observational study.
Control group
Active

Outcomes
Primary outcome [1] 294743 0
Identify association between high levels of interleukin-6 (IL-6) at baseline and the incidence of postoperative cognitive dysfunction as measured by a neuropsychological test battery at 3 months following surgery.
Timepoint [1] 294743 0
Neuropsychological testing at baseline (prior to surgery) and 3 months postoperatively will be undertaken at the patient's home. Blood samples will be taken prior to anaesthetic induction as a baseline measurement and again at 30 minutes following surgical incision and at 6, 24 and 48 hours following surgery.
Secondary outcome [1] 313982 0
To identify associations between fluctuating levels of interleukin-6 (IL-6) in response to anaesthesia and surgery and postoperative delirium up to 5 days following surgery. In addition, exploratory analyses will be undertaken to identify known and unknown biomarkers of delirium, cognitive decline, and neuronal injury.
Timepoint [1] 313982 0
Blood samples will be taken prior to anaesthetic induction as a baseline measurement and again at 30 minutes following surgical incision and at 6, 24 and 48 hours following surgery. Postoperative delirium will be assessed twice daily up to 5 days follow surgery or until discharge. Delirium assessments will be conducted by trained research staff using the 3 minute Diagnostic Confusion Assessment Method (3D-CAM).
Secondary outcome [2] 380288 0
To assess changes in cognitive function at 1-3 years following surgery as measured by a neuropsychological test battery. The neuropsychological test battery comprises of a series of assessments that enable us to identify post-operative cognitive dysfunction. We have successfully used this battery in a number of investigations. The components of the battery are as follows: memory (CERAD word learning test - immediate and delayed recall); attention (Trail Making A); executive function (Trail Making B, Digit Symbol Substitution Test, Clock Drawing Test); semantic fluency (controlled oral word association); verbal fluency (FAS); and motor function (Grooved Pegboard - dominant and non-dominant). We also administer the Mini-Mental State Examination as part of the neuropsychological test battery (composite primary outcome).
Timepoint [2] 380288 0
Neuropsychological assessment at 1-3 years postoperatively.

Eligibility
Key inclusion criteria
1. Aged 60 years or older
2. Scheduled for elective health care procedure
3. No contraindication to neuropsychological testing (eg. language, significant depression, deaf or blind)
4. Live within a reasonable proximity of St Vincent's Hospital (for home neuropsychological assessments)
5. Expected length of hospital stay of 3 days or more
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Pre-existing neurological or clinically evident nerovascular disease (eg stroke)
2. Mini Mental State Examination of 26 and below
3. Anticipated difficulty with neuropsychological assessment
4. Inaccessibility (patients living over 1 hour drive from Melbourne)
5. Age (patients less than 60 years of age)
6. Anticipated length of stay in hospital less than 3 days

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
From pilot data (vide supra,), we based power calculations on a difference in mean (SD) of those patients with cognitive impairment at 3 months of 3.65 (4.25) pg/mL, and without cognitive impairment at 3 months of 1.71 (0.53) pg/mL. Assuming a power of 80% and alpha = 0.05, we would require 39 patients in each group to detect a significant difference in the level of IL-6 between those with cognitive impairment at 3 months and those without. Allowing for a loss to follow-up (all cause) of 15%, we plan to recruit 90 patients over 18 months.
A logistic regression model will be used to detect risk factors and predictors, particularly the levels of inflammatory markers including IL-6, TNF-a, for cognitive outcome to 3 months. Additionally, multivariable analyses will be performed to look at pertinent risk factors for postoperative delirium and postoperative cognitive dysfunction including inflammatory markers in blood, peri-operative morbidities and demographics.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
10/05/2015
Date of last participant enrolment
Anticipated
10/05/2017
Actual
25/01/2018
Date of last data collection
Anticipated
Actual
3/06/2019
Sample size
Target
90
Accrual to date
Final
90
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 3683 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment postcode(s) [1] 9510 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 291055 0
Other Collaborative groups
Name [1] 291055 0
Australia and New Zealand College of Anaesthetists
Country [1] 291055 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital
Address
PO Box 2900
Fitzroy
VIC 3065
Country
Australia
Secondary sponsor category [1] 289739 0
None
Name [1] 289739 0
Address [1] 289739 0
Country [1] 289739 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292643 0
St Vincent's Hospital HREC-A
Ethics committee address [1] 292643 0
Ethics committee country [1] 292643 0
Australia
Date submitted for ethics approval [1] 292643 0
19/01/2015
Approval date [1] 292643 0
05/03/2015
Ethics approval number [1] 292643 0
HREC-A 004/15

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 56366 0
A/Prof Brendan Silbert
Address 56366 0
St Vincent's Hospital
PO Box 2900
Fitzroy
VIC 3065
Country 56366 0
Australia
Phone 56366 0
+61 3 9231 4197
Fax 56366 0
Email 56366 0
[email protected]
Contact person for public queries
Name 56367 0
Erika Fortunato
Address 56367 0
St Vincent's Hospital
PO Box 2900
Fitzroy
VIC 3065
Country 56367 0
Australia
Phone 56367 0
+61 3 9231 2072
Fax 56367 0
Email 56367 0
[email protected]
Contact person for scientific queries
Name 56368 0
Lisbeth Evered
Address 56368 0
St Vincent's Hospital
PO Box 2900
Fitzroy
VIC 3065
Country 56368 0
Australia
Phone 56368 0
+61 3 9231 2251
Fax 56368 0
Email 56368 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
It is intended that the IPD will be made available for this trial but specific details have not yet been ascertained.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
6967Study protocol  [email protected]
6968Statistical analysis plan  [email protected]
6969Informed consent form  [email protected]
6970Clinical study report  [email protected]
6971Ethical approval  [email protected]
6972Analytic code  [email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.