ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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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

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]

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)

Condition category

Condition code

Surgery

Other surgery

Anaesthesiology

Anaesthetics

Mental Health

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]

Treatment: Other

Comparator / control treatment

Control group

Dose comparison

Outcomes

Primary outcome [1]

Frequency of POCD

Timepoint [1]

12 months post surgery

Secondary outcome [1]

Length of time in ICU

Timepoint [1]

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]

Length of stay in hospital

Timepoint [2]

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]

Cumulative incidence of death and complications.

Timepoint [3]

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?

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]

Government body

Name [1]

National Health and Medical Research Council

Address [1]

National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601

Country [1]

Australia

Funding source category [2]

Other Collaborative groups

Name [2]

Australian and New Zealand College of Anaesthetists (ANZCA)

Address [2]

St Kilda Road, Melbourne

Country [2]

Australia

Primary sponsor type

Individual

Name

Dr. Brendan Silbert

Address

Country

Secondary sponsor category [1]

Individual

Name [1]

A/Prof. David Scott

Address [1]

Department of Anaesthesia, St. Vincent's Hospital, PO Box 2900, Fitzroy 3065

Country [1]

Australia

Secondary sponsor category [2]

Individual

Name [2]

A/Prof. Paul Maruff

Address [2]

Neurosciences Department, University of Melbourne, Parkville, Victoria

Country [2]

Australia

Secondary sponsor category [3]

Individual

Name [3]

A/Prof Paul Myles

Address [3]

Department of Anaesthesia and Pain Management, Alfred Hospital, Commercial Road, Prahran

Country [3]

Australia

Secondary sponsor category [4]

Individual

Name [4]

A/Prof Konrad Jamrozik

Address [4]

c/o St. Vincent's Hospital, PO Box 2900, Fitzroy 3065

Country [4]

Australia

Secondary sponsor category [5]

Individual

Name [5]

Ms. Lis Evered

Address [5]

Department of Anaesthesia, St. Vincent's Hospital, PO Box 2900, Fitzroy 3065

Country [5]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

St. Vincent's Hospital Melbourne

Ethics committee address [1]

PO Box 2900 
Fitzroy 3065

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

01/01/2001

Ethics approval number [1]

004/01

Ethics committee name [2]

St. Vincent's Private Hospital

Ethics committee address [2]

Melbourne

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

Approval date [2]

01/06/2001

Ethics approval number [2]

Ethics committee name [3]

Alfred Hospital

Ethics committee address [3]

Melbourne

Ethics committee country [3]

Australia

Date submitted for ethics approval [3]

Approval date [3]

Ethics approval number [3]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Dr. Brendan Silbert

Address

Department of Anaesthesia
St. Vincent's Hospital
PO Box 2900
Fitzroy VIC 3065

Country

Australia

Phone

+61 3 92884253

Fax

+61 3 92884255

brendan.silbert@svhm.org.au

Contact person for scientific queries

Name

Ms. Lis Evered

Address

Department of Anaesthesia
St. Vincent's Hospital
PO Box 2900
Fitzroy VIC 3065

Country

Australia

Phone

+61 3 92882251

Fax

+61 3 92884255

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

Source	Title	Year of Publication	DOI
Embase	Prevalence of Dementia 7.5 Years after Coronary Artery Bypass Graft Surgery.	2016	https://dx.doi.org/10.1097/ALN.0000000000001143

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically