Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000049471
Ethics application status
Approved
Date submitted
21/12/2006
Date registered
16/01/2007
Date last updated
19/11/2019
Date data sharing statement initially provided
19/11/2019
Date results information initially provided
19/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Anaesthesia Cognitive Evaluation (ACE) Study
Scientific title
The prospective, descriptive ACE (Anaesthesia Cognitive Evaluation) Study will identify whether preoperative cognitive impairment (Mild Cognitive Impairment (MCI)) increases the risk of PostOperative Cognitive Dysfunction (POCD) in elderly patients undergoing non-cardiac surgery (elective Total Hip Replacement (THR)) compared to a concurrent control group of medically managed patients with osteoarthritis (OA).
Secondary ID [1] 260027 0
nil
Universal Trial Number (UTN)
Trial acronym
The ACE Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients with osteoarthritis which is medically managed and those requiring total hip replacement surgery. 1542 0
Condition category
Condition code
Musculoskeletal 1641 1641 0 0
Osteoarthritis

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
To test whether MCI increases the risk of POCD following THR and to compare the change in cognitive function in patients undergoing THR for OA with a control group of patients who have OA that is managed medically. Medical management will be the use of anti-inflammatory medications as clinically indicated and prescribed by the treating physician. Patients will complete a battery of conventional and computerised neuropsychological tests preoperatively, and at 6 days, 3 months and 12 months post-operatively. The conventional battery is a set of eight paper and pencil tests (eg. trail making tests A and B, digit symbol test, Rey Auditory Verbal Learning test) and the computerised battery is a version of Cogstate®. The tests take about 1 hours to complete. Quality of Life (QoL), mood characteristics, Activities of Daily Living (ADL) and Clinical Dementia Rating (CDR) will be assessed preoperatively and 3 and 12 months post-operatively.
Intervention code [1] 1521 0
Early detection / Screening
Comparator / control treatment
Control group: patients who have OA that is managed medically. The control group will complete the same tests at corresponding intervals.
Control group
Active

Outcomes
Primary outcome [1] 2263 0
Mild Cognitive Impairment (MCI)
Timepoint [1] 2263 0
Baseline
Primary outcome [2] 2264 0
Post Operative Cognitive Dysfunction (POCD)
Timepoint [2] 2264 0
At 6 days, 3 and 12 months
Secondary outcome [1] 3953 0
Length of stay in hospital
Timepoint [1] 3953 0
6 days
Secondary outcome [2] 3954 0
Natural history of POCD
Timepoint [2] 3954 0
6 days, 3 and 12 months
Secondary outcome [3] 3955 0
Risk factors for POCD
Timepoint [3] 3955 0
6 days, 3 and 12 months
Secondary outcome [4] 3956 0
Severity of POCD
Timepoint [4] 3956 0
6 days, 3 and 12 months
Secondary outcome [5] 3957 0
Incidence of complications
Timepoint [5] 3957 0
6 days, 3 and 12 months

Eligibility
Key inclusion criteria
Scheduled for elective hip replacement surgery for osteoarthritis or control patients with medically managed osteoarthritis who: do not have neurological deficit; give informed consent; have no contraindication to neuropsychological testing. The patients must reside in accessible proximity to the hospital to enable investigators to administer baseline neuropsychological testing at home.
Minimum age
60 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1.Pre-existing neurological or clinically evident neurovascular disease (e.g. TIA, stroke);2.Score of less than 26 on the Mini Mental State Examination or CDR>1 (i.e. exclude dementia);3.Anticipated difficulty with neuropsychological assessment, such as English not being the prime language, blindness, deafness;4.Associated medical problems that may lead to significant complications and subsequent loss to follow-up (ASA Physical Status IV or higher);Geographical remoteness that may make it difficult to test patients at home.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2007
Actual
3/08/2007
Date of last participant enrolment
Anticipated
Actual
14/01/2013
Date of last data collection
Anticipated
Actual
6/12/2017
Sample size
Target
400
Accrual to date
Final
365
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1787 0
Government body
Name [1] 1787 0
National Health and Medical Research Council Project Grant # 454440
Country [1] 1787 0
Australia
Primary sponsor type
Individual
Name
A/Prof Brendan Silbert
Address
Department of Anaesthesia, St. Vincent's Hospital, PO Box 2900 Fitzroy Victoria 3065
Country
Australia
Secondary sponsor category [1] 1593 0
Individual
Name [1] 1593 0
A/Prof David Scott
Address [1] 1593 0
Department of Anaesthesia, St. Vincent's Hospital, PO Box 2900 Fitzroy 3065
Country [1] 1593 0
Australia
Secondary sponsor category [2] 1594 0
Individual
Name [2] 1594 0
Prof Peter Choong
Address [2] 1594 0
Department of Orthopaedics, St. Vincent's Hospital, PO Box 2900 Fitzroy 3065
Country [2] 1594 0
Australia
Secondary sponsor category [3] 1595 0
Individual
Name [3] 1595 0
Prof David Ames
Address [3] 1595 0
St. Georges Campus, St. Vincent's Hospital, PO Box 2900 Fitzroy 3065
Country [3] 1595 0
Australia
Secondary sponsor category [4] 1596 0
Individual
Name [4] 1596 0
Prof Paul Maruff
Address [4] 1596 0
Neurosciences Department, Unitversity of Melbourne, Parkville, Victoria
Country [4] 1596 0
Australia
Secondary sponsor category [5] 1597 0
Individual
Name [5] 1597 0
Prof Konrad Jamrozik
Address [5] 1597 0
c/o St. Vincent's Hospital, PO Box 2900 Fitzroy 3065
Country [5] 1597 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304764 0
St Vincent's Hospital HREC-A
Ethics committee address [1] 304764 0
PO Box 2900 Fitzroy VIC 3065
Ethics committee country [1] 304764 0
Australia
Date submitted for ethics approval [1] 304764 0
Approval date [1] 304764 0
17/01/2007
Ethics approval number [1] 304764 0
171/06

Summary
Brief summary
The ACE (Anaesthesia Cognitive Evaluation) Study is a prospective descriptive comparison of the prevalence of MCI (Mild Cognitive Impairment) and the incidence of POCD (Post Operative Cognitive Dysfunction) in patients undergoing THR (Total Hip Replacement) for OA (Osteoarthritis) and a control group of patients who have OA (Osteoarthritis) that is managed medically.
Trial website
www.cognition.org.au
Trial related presentations / publications
1) Evered LA, Silbert BS, Scott DA, Maruff P, Ames D, Choong P. Pre-existing Cognitive Impairment and Mild Cognitive Impairment in Subjects Presenting for Total Hip Joint Replacement. Anesthesiology 2011;114(6):1297-304
2) Evered LA, Scott DA, Silbert BS, Maruff P. Post Operative Cognitive Dysfunction is Independent of Type of Surgery and Anesthetic. Anesth and Analg 2011;112(5):1179-85
3) Silbert B; Evered LA; Scott DA; McMahon S; Choong P; Ames D; Maruff P; Jamrozik K. Pre-existing cognitive impairment is associated with postoperative cognitive dysfunction after non-cardiac surgery. Anesthesiology 2015; 122(6):1224-34
4) Evered LA; Silbert B; Scott DA; Ames D; Maruff P; Blennow K; Zetterberg H. Cerebrospinal fluid analysis in patients undergoing hip replacement predicts cognitive dysfunction. Anesthesiology 2016; 124:353-61. DOI: 10.1097/ALN.0000000000000953
Public notes

Contacts
Principal investigator
Name 27455 0
A/Prof Brendan Silbert
Address 27455 0
Department of Anaesthesia - St Vincent's Hospital, PO Box 2900 Fitzroy VIC 3065
Country 27455 0
Australia
Phone 27455 0
+61 3 9288 4253
Fax 27455 0
Email 27455 0
brendan.silbert@svhm.org.au
Contact person for public queries
Name 10710 0
A/Prof Lis Evered
Address 10710 0
Department of Anaesthesia
St. Vincent’s Hospital
P.O. Box 2900
Fitzroy, Melbourne VIC 3065
Country 10710 0
Australia
Phone 10710 0
+61 3 92882251
Fax 10710 0
+61 3 92884255
Email 10710 0
lis.evered@svhm.org.au
Contact person for scientific queries
Name 1638 0
A/Prof Associate Professor Brendan Silbert
Address 1638 0
Department of Anaesthesia
St. Vincent’s Hospital
P.O. Box 2900
Fitzroy, Melbourne VIC 3065
Country 1638 0
Australia
Phone 1638 0
+61 3 92884253
Fax 1638 0
+61 3 92884255
Email 1638 0
brendan.silbert@svhm.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
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
SourceTitleYear of PublicationDOI
EmbasePreexisting Cognitive Impairment Is Associated with Postoperative Cognitive Dysfunction after Hip Joint Replacement Surgery.2015https://dx.doi.org/10.1097/ALN.0000000000000671
EmbaseCerebrospinal Fluid Biomarker for Alzheimer Disease Predicts Postoperative Cognitive Dysfunction.2016https://dx.doi.org/10.1097/ALN.0000000000000953
Dimensions AIPostoperative Cognitive Dysfunction after Sevoflurane Or Propofol General Anaesthesia in Combination with Spinal Anaesthesia for Hip Arthroplasty2018https://doi.org/10.1177/0310057x1804600610
N.B. These documents automatically identified may not have been verified by the study sponsor.