Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000744651
Ethics application status
Approved
Date submitted
27/03/2023
Date registered
10/07/2023
Date last updated
20/11/2023
Date data sharing statement initially provided
10/07/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating Perioperative Outcomes after Surgical Events: IMPOSE
Scientific title
Investigating Perioperative Outcomes after Surgical Events
Secondary ID [1] 308727 0
None
Universal Trial Number (UTN)
Trial acronym
IMPOSE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
delirium 330382 0
neurological inflammation 330383 0
postoperative management 330385 0
Condition category
Condition code
Neurological 327225 327225 0 0
Other neurological disorders

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
1
Target follow-up type
Years
Description of intervention(s) / exposure
Prior to surgery patients who consent for this study will undergo a cognitive screen in the pre-admission clinic prior to surgery. This assessment will include the modified telephone cognitive screen (TICS-M), 3D CAM, Richmond Agitation and Sedation Scale, Pain scale and the Healthy Brain Aging clinic questionnaire. Additionally the anaesthetic doctor will collect a blood sample prior to incision on the day of surgery. This sample will be sent to pathology for measurement of inflammatory markers (WCC, Troponin and CRP), and some plasma will be aliquoted and stored in the labaratory for biomarker analysis. Patients will be observed and assessed on postoperative days 1-4 in both the morning and evening. During these assessments they will complete the 3D Cam and have some blood collected to be measured for the same tests as per the pre-operative bloods. If a patient scores positively for delirium at any point during the postoperative days 1-4, they will be offered referral to the Healthy Brain Aging Clinic at the University of Sydney and provided a referral letter by the Principal Investigator on discharge. The patient will be provided information about the Healthy Brain Aging Clinic along with the referral and will be made aware that it will be their responsibility to contact the clinic to arrange an appointment. The PI/research team will not be invovled in their ongoing relationship with the HBA. Currently patients who score positively for delirirum postoperatively will be monitored and treated as necesary by their medical team, however a referral to the HBA is not standard practice. Outside of this study, if a patient required ongoing care for delirium, it would occur through their GP who would be alerted to issues with cognitive function/delirium during their inpatient stay.
At one-year post-surgery the patient will be called and asked to complete the TICS-M again (on the phone) as well as the HBA questionnaire. Additionally if referred to the HBA during their stay in hospital the research team will collect data on their interaction with the clinic.
Intervention code [1] 325729 0
Early Detection / Screening
Comparator / control treatment
Standard care. Currently if a patient experiences postoperative delirium they will be treated appropriately as an inpatient but will not be referred for ongoing care at the Healthy Brain Aging Clinic, Their GP or medical treating team may be invovled for ongoing management if required.
Control group
Active

Outcomes
Primary outcome [1] 335108 0
Change in Neurofilament light (NfL) as measured from a blood test analysis on postoperative day 1 in comparison to pre-operative NfL
Timepoint [1] 335108 0
1 day postoperative
Primary outcome [2] 335109 0
Change in cognitive function in 1 year, measured by Telephone Interview for Cognitive Status (TICS-M)
Timepoint [2] 335109 0
1 year postoperative
Secondary outcome [1] 423044 0
The association between postoperative day 1 change in NfL and 1 year change in Verbal and Semantic Fluency score (COWAT).
Timepoint [1] 423044 0
1 Year postoperative
Secondary outcome [2] 423045 0
The association between postoperative day 1 change in NfL and 1 year change in Verbal Fluency score
Timepoint [2] 423045 0
1 year postoperatively
Secondary outcome [3] 423046 0
The association between postoperative day 1 change in NfL and 1 year change in frailty score
Timepoint [3] 423046 0
1 year post operatively
Secondary outcome [4] 423047 0
The association between postoperative day 1 change in NfL and 1 year change in function score. as measured by the Healthy Brain Aging Clinic Questionairre.
Timepoint [4] 423047 0
1 year postoperatively
Secondary outcome [5] 423049 0
Associations of biomarkers with postoperative peak delirium as measured by the 3D CAM severity and biomarkers (NfL)
Timepoint [5] 423049 0
Assessed daily in the morning and afternoon on postoperative days 1, 2, 3 and 4. Blood biomarkers will be collected once in the morning,
Secondary outcome [6] 423050 0
The incidence of delirium (3D-Confusion Assessment Method (CAM) or (CAM ICU)
Timepoint [6] 423050 0
Assessed daily in the morning and afternoon on postoperative days 1, 2, 3 and 4.
Secondary outcome [7] 423051 0
Instance of Delirium severity (3D-CAM-S or CAM-ICU-7)
Timepoint [7] 423051 0
post operative day 4
Secondary outcome [8] 423052 0
Changes in plasma troponin measured in blood samples
Timepoint [8] 423052 0
Assessed once daily on postoperative days 1, 2, 3 and 4 (bloods collected in morning).
Secondary outcome [9] 423053 0
Incidence of postoperative memory complaints as self-reported by patients
Timepoint [9] 423053 0
1 year postoperative
Secondary outcome [10] 423054 0
Instance of follow up at Healthy Brain Aging as self-reported by the patient at 1-year postoperative telephone call
Timepoint [10] 423054 0
1 year postoperative
Secondary outcome [11] 423055 0
Association between follow up at the Healthy Brain Aging Clinic and quality of life measured by the HBA questionnaire
Timepoint [11] 423055 0
1 year postoperative

Eligibility
Key inclusion criteria
Patients over 60 years old undergoing major surgery requiring a two-day stay
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Non-english speaking
Participants who may have received an investigational new drug within the last 7 days/weeks.
Participants with a history of a psychological illness or other conditions which may interfere with their ability to understand the study requirements or provide consent such as pre-existing dementia.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Analysis of the primary outcome will be with linear regression with age, sex and preoperative TICS-M score adjustment of POD1 change in NfL as a predictor of one-year TICS-M

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
31/07/2023
Actual
16/08/2023
Date of last participant enrolment
Anticipated
1/01/2025
Actual
Date of last data collection
Anticipated
5/01/2026
Actual
Sample size
Target
120
Accrual to date
24
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 24349 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 24933 0
The Chris O’Brien Lifehouse - Camperdown
Recruitment postcode(s) [1] 39919 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 314096 0
Hospital
Name [1] 314096 0
Royal Prince Alfred Hospital
Country [1] 314096 0
Australia
Primary sponsor type
Government body
Name
Sydney Local Health District (SLHD)
Address
50 Missenden Road
Camperdown
NSW 2050
Country
Australia
Secondary sponsor category [1] 315258 0
None
Name [1] 315258 0
Address [1] 315258 0
Country [1] 315258 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312221 0
Sydney Local Health District (SLHD) HREC (RPAH Zone)
Ethics committee address [1] 312221 0
Ethics committee country [1] 312221 0
Australia
Date submitted for ethics approval [1] 312221 0
26/05/2023
Approval date [1] 312221 0
02/06/2023
Ethics approval number [1] 312221 0
2023/ETH0092

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

Contacts
Principal investigator
Name 123898 0
Prof Robert Sanders
Address 123898 0
RPAH
Bldg 89 Level 4
50 Missenden Road
Camperdown NSW 2050
Country 123898 0
Australia
Phone 123898 0
+61 2 95158507
Fax 123898 0
Email 123898 0
[email protected]
Contact person for public queries
Name 123899 0
Kaitlin Kramer
Address 123899 0
RPAH
Bldg 89 Level 4
50 Missenden Road
Camperdown NSW 2050
Country 123899 0
Australia
Phone 123899 0
+61 2 95158789
Fax 123899 0
Email 123899 0
[email protected]
Contact person for scientific queries
Name 123900 0
Robert Sanders
Address 123900 0
RPAH
Bldg 89 Level 4
50 Missenden Road
Camperdown NSW 2050
Country 123900 0
Australia
Phone 123900 0
+61 295158507
Fax 123900 0
Email 123900 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


What supporting documents are/will be available?

No Supporting Document Provided



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.