Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000285651
Ethics application status
Approved
Date submitted
10/08/2005
Date registered
5/09/2005
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
Retrospectively registered

Titles & IDs
Public title
The AustraliaN Trial Investigating Post Operative Deficit, Early extubation and Survival (ANTIPODES)
Scientific title
The prospective randomised controlled ANTIPODES Trial will test whether early extubation following coronary artery graft surgery (CAGS) and the perioperative anaesthetic management that permits early extubation, results in a significant reduction in postoperative cognitive dysfunction in the short and medium term.
Secondary ID [1] 260030 0
nil
Universal Trial Number (UTN)
Trial acronym
The ANTIPODES Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post Operative Cognitive Dysfunction (POCD) 373 0
Condition category
Condition code
Surgery 440 440 0 0
Other surgery
Anaesthesiology 441 441 0 0
Anaesthetics
Mental Health 442 442 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
To test whether early extubation following CAGS results in a significant reduction in the incidence of POCD. Low dose anaesthesia permitting early extubation will consist of routine clinical practice using fentanyl 10 micrograms/kg, propofol as required. High dose fentanyl anaesthesia will consist of routine clinical practice using fentanyl 50 micrograms/kg, propofol as required. Patients will complete a battery of neuropsychological tests preoperatively, and 6 days, 3 months and 12 months postoperatively. Quality of life and depression will be assessed preoperatively and at 3 months and 12 months postoperatively.
Intervention code [1] 159 0
Treatment: Other
Comparator / control treatment
Control group
Dose comparison

Outcomes
Primary outcome [1] 500 0
Frequency of POCD
Timepoint [1] 500 0
12 months post surgery
Secondary outcome [1] 1081 0
Length of time in ICU
Timepoint [1] 1081 0
Primary outcome is POCD at 12 months post surgery, secondary outcomes to identify predictors. Length of time in ICU will be assessed via accessing patient records through the hospital's internal system. Specifically the patient's ICU discharge summary will be consulted, as well as their bed transfer information.
Secondary outcome [2] 1082 0
Length of stay in hospital
Timepoint [2] 1082 0
Primary outcome is POCD at 12 months post surgery, secondary outcomes to identify predictors. Length of stay in hospital will be assessed via accessing patient records through the hospital's internal system.
Secondary outcome [3] 1083 0
Cumulative incidence of death and complications.
Timepoint [3] 1083 0
Primary outcome is POCD at 12 months post surgery, secondary outcomes to identify predictors. Incidence of death and complications will be assessed via accessing patient records through the hospital's internal system.

Eligibility
Key inclusion criteria
Scheduled for first time coronary artery bypass surgery, who give written informed consent. Patients must be suitable for neuropsychological testing and without neurological deficit.
Minimum age
55 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Poor left ventricular function (ejection fraction < 30%); 2. major systemic illness contraindicating early extubation (eg. chronic respiratory impairment); 3. pre-existing neurological disease (eg. stroke); 4. anticipated difficulty with neuropsychological assessment such as English not being the prime language.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed envelope allocated to each patient and distributed to anaesthetist immediately prior to surgery.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Generated from a table of random numbers. The restriction method will be random permuted blocks. Sequence will be stratified for hospital (site) and off-pump/om-pump.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
18/04/2001
Actual
17/04/2001
Date of last participant enrolment
Anticipated
Actual
10/12/2003
Date of last data collection
Anticipated
Actual
27/11/2004
Sample size
Target
350
Accrual to date
Final
349
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 493 0
Government body
Name [1] 493 0
National Health and Medical Research Council
Country [1] 493 0
Australia
Funding source category [2] 264915 0
Other Collaborative groups
Name [2] 264915 0
Australian and New Zealand College of Anaesthetists (ANZCA)
Country [2] 264915 0
Australia
Primary sponsor type
Individual
Name
Dr. Brendan Silbert
Address
Country
Secondary sponsor category [1] 395 0
Individual
Name [1] 395 0
A/Prof. David Scott
Address [1] 395 0
Department of Anaesthesia, St. Vincent's Hospital, PO Box 2900, Fitzroy 3065
Country [1] 395 0
Australia
Secondary sponsor category [2] 396 0
Individual
Name [2] 396 0
A/Prof. Paul Maruff
Address [2] 396 0
Neurosciences Department, University of Melbourne, Parkville, Victoria
Country [2] 396 0
Australia
Secondary sponsor category [3] 397 0
Individual
Name [3] 397 0
A/Prof Paul Myles
Address [3] 397 0
Department of Anaesthesia and Pain Management, Alfred Hospital, Commercial Road, Prahran
Country [3] 397 0
Australia
Secondary sponsor category [4] 398 0
Individual
Name [4] 398 0
A/Prof Konrad Jamrozik
Address [4] 398 0
c/o St. Vincent's Hospital, PO Box 2900, Fitzroy 3065
Country [4] 398 0
Australia
Secondary sponsor category [5] 399 0
Individual
Name [5] 399 0
Ms. Lis Evered
Address [5] 399 0
Department of Anaesthesia, St. Vincent's Hospital, PO Box 2900, Fitzroy 3065
Country [5] 399 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1468 0
St. Vincent's Hospital Melbourne
Ethics committee address [1] 1468 0
PO Box 2900
Fitzroy 3065
Ethics committee country [1] 1468 0
Australia
Date submitted for ethics approval [1] 1468 0
Approval date [1] 1468 0
01/01/2001
Ethics approval number [1] 1468 0
004/01
Ethics committee name [2] 1469 0
St. Vincent's Private Hospital
Ethics committee address [2] 1469 0
Melbourne
Ethics committee country [2] 1469 0
Australia
Date submitted for ethics approval [2] 1469 0
Approval date [2] 1469 0
01/06/2001
Ethics approval number [2] 1469 0
Ethics committee name [3] 1470 0
Alfred Hospital
Ethics committee address [3] 1470 0
Melbourne
Ethics committee country [3] 1470 0
Australia
Date submitted for ethics approval [3] 1470 0
Approval date [3] 1470 0
Ethics approval number [3] 1470 0

Summary
Brief summary
Trial website
www.cognition.org.au
Trial related presentations / publications
1) Silbert BS, Maruff P, Evered LA, Scott DA, Kalpokas M, Martin KJ, et al. Detection of cognitive decline after coronary surgery: a comparison of computerized and conventional tests. Br J Anaesth 2004;92(6):814-20
2) Lewis MS, Maruff P, Silbert BS, Evered LA, Scott DA. The influence of different error estimates in the detection of post-operative cognitive dysfunction using reliable change indices with correction for practice effects. Arch Clin Neuropsychol 2006;21(5):421-7
3) Lewis MS, Maruff P, Silbert BS, Evered LA, Scott DA. Detection of postoperative cognitive decline after coronary artery bypass graft surgery is affected by the number of neuropsychological tests in the assessment battery. Ann Thorac Surg 2006;81(6):2097-104
4) Lewis MS, Maruff P, Silbert BS, Evered LA, Scott DA. The sensitivity and specificity of three common statistical rules for the classification of post-operative cognitive dysfunction following coronary artery bypass graft surgery. Acta Anaesthesiol Scand 2006;50(1):50-7
5) Silbert BS, Scott DA, Evered LA, Lewis MS, Kalpokas M, Maruff P, et al. A comparison of the effect of high- and low-dose fentanyl on the incidence of postoperative cognitive dysfunction after coronary artery bypass surgery in the elderly. Anesthesiology 2006;104(6):1137-45
6) Silbert B, Scott D, Evered L, Lewis M, Maruff P. Pre-existing cognitive impairment in patients for elective coronary artery bypass graft surgery. Anesth and Analg 2007;104(5):1023-8
7) Silbert, B., Evered, L., Scott, D., McCutcheon, C., Jamrozik, K. Homocysteine and c-reactive protein are not markers of cognitive impairment in patients with major cardiovascular disease. Dement Geriatr Cogn Disord 2008;25(4): 309-16
8) Silbert, B. S., L. A. Evered, et al. The apolipoprotein E epsilon4 allele is not associated with cognitive dysfunction in cardiac surgery. Ann Thorac Surg 2008;86(3): 841-7
9) Evered, L.A., Silbert, B., Scott,D.A., Maruff,P., Laughton,K.M., Volitakis,I., Cowie,T., Cherny,R.A., Masters,C.L., Li,Q-X. Plasma Aß42 and Aß40 Levels Predict Early Cognitive Dysfunction after Cardiac Surgery - Ann Thorac Surg 2009;88:1426-32
10) Evered, L.A., Silbert,B.S., Scott,D.A. Postoperative Cognitive Dysfunction and Aortic Atheroma. Ann Thorac Surg 2010;89:1091-7
11) 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
12) Evered LA; Silbert B; Scott DA; Maruff P; Ames DA. A prospective study of the prevalence of dementia 7.5 years following coronary artery bypass graft surgery. Anesthesiology 2016; 125:62-71
Public notes

Contacts
Principal investigator
Name 35724 0
Address 35724 0
Country 35724 0
Phone 35724 0
Fax 35724 0
Email 35724 0
Contact person for public queries
Name 9348 0
Dr. Brendan Silbert
Address 9348 0
Department of Anaesthesia
St. Vincent's Hospital
PO Box 2900
Fitzroy VIC 3065
Country 9348 0
Australia
Phone 9348 0
+61 3 92884253
Fax 9348 0
+61 3 92884255
Email 9348 0
brendan.silbert@svhm.org.au
Contact person for scientific queries
Name 276 0
Ms. Lis Evered
Address 276 0
Department of Anaesthesia
St. Vincent's Hospital
PO Box 2900
Fitzroy VIC 3065
Country 276 0
Australia
Phone 276 0
+61 3 92882251
Fax 276 0
+61 3 92884255
Email 276 0
lis.evered@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
EmbasePrevalence of Dementia 7.5 Years after Coronary Artery Bypass Graft Surgery.2016https://dx.doi.org/10.1097/ALN.0000000000001143
N.B. These documents automatically identified may not have been verified by the study sponsor.