ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12607000004460

Ethics application status

Approved

Date submitted

7/12/2006

Date registered

4/01/2007

Date last updated

22/02/2008

Type of registration

Prospectively registered

Titles & IDs

Public title

The effect of remote ischaemic preconditioning on lowering postoperative myocardial troponin I release in children with congenital heart disease undergoing cardiopulmonary bypass.

Scientific title

The effect of remote ischaemic preconditioning on lowering postoperative myocardial troponin I release in children with congenital heart disease undergoing cardiopulmonary bypass.

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Congenital heart disease witithin neonates

Condition category

Condition code

Cardiovascular

Other cardiovascular diseases

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Preconditioning as a method of myocardial protection at the time of repair of congenital heart disease. Patients will be randomised to control or remote ischaemic preconditioning. The remote ischaemic preconditioning protocol will be by 4 cycles of 5 minutes of lower limb ischaemia induced by inflating a blood pressure cuff to 15 mmHg greater than systolic blood pressure placed around the thigh, followed by 5 minutes of reperfusion.

Intervention code [1]

Prevention

Comparator / control treatment

Controls will have the blood pressure cuff placed loosely around the thigh but not inflated. The total time for the preconditioning protocol and the sham is therefore 40 minutes.

Control group

Placebo

Outcomes

Primary outcome [1]

Postoperative levels of troponin I will be measured from blood samples

Timepoint [1]

Blood samples taken immediately preoperatively and then at 3, 6 and 24 hours postoperatively.

Secondary outcome [1]

Cardiac output, lung function, systemic inflammatory response.

Timepoint [1]

Each of these will be assessed at 3, 6 and 24 hours postoperatively.

Secondary outcome [2]

Inflammatory response in the form of blood levels of TNF-alpha.

Timepoint [2]

Assessed immediately preoperatively.

Eligibility

Key inclusion criteria

Neonates undergoing open heart surgery for repair of congenital defects will be recruited. Specifically, children undergoing the arterial switch procedure and the Norwood procedure will be studied.

Minimum age

1 Days

Maximum age

28 Days

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Patients with chromosomal defects, associated congenital lung malformations, and haematological disorders and those older than 28 days will be excluded.

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Sealed opaque envelopes

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Randomisation will be by block and stratified by the two diagnostic groups (Norwood and Transposition).

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Subjects, laboratory staff analying blood samples, bedside medical staff will all be blinded.

Phase

Phase 1

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

2/01/2008

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Heart Foundation

Address [1]

411 King StreetWest
Melbourne VIC 3003

Country [1]

Australia

Funding source category [2]

Charities/Societies/Foundations

Name [2]

Heartkids and Manchester Unity

Address [2]

Manchester Unity Building
Level 9, 205 Pacific Highway
St Leonards NSW 2065

Country [2]

Australia

Primary sponsor type

Individual

Name

Michael Cheung

Address

Royal Childrens Hospital, Parkville, Victoria 3052

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

Lara Shekerdemian

Address [1]

Royal Childrens Hospital, Parkville, VIC 3052

Country [1]

Australia

Secondary sponsor category [2]

Individual

Name [2]

Ian Mackenzie

Address [2]

Royal Childrens Hospital, Parkville, VIC 3052

Country [2]

Australia

Secondary sponsor category [3]

Individual

Name [3]

Yves D'Udekem

Address [3]

Royal Childrens Hospital, Parkville, VIC 3052

Country [3]

Australia

Secondary sponsor category [4]

Individual

Name [4]

Steve Horten

Address [4]

Royal Childrens Hospital, Parkville, VIC 3052

Country [4]

Australia

Secondary sponsor category [5]

Individual

Name [5]

Polly Hardy

Address [5]

Royal Childrens Hospital, Parkville, VIC 3052

Country [5]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Ethics and Human Research Committee of the Royal Childrens Hospital Melbourne

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

01/05/2006

Approval date [1]

14/03/2007

Ethics approval number [1]

26091A

Summary

Brief summary

Support of the circulation during heart surgery using the heart-lung bypass machine is inevitably associated with organ damage and associated reduced function. This is due to reduced blood flow (ischaemia), the effects of restoration of flow (reperfusion injury) and the subsequent inflammation that is caused. The body has its own way of protecting itself against reduced blood flow and oxygen by a mechanism known as preconditioning. In essence, brief periods of mild ischaemia are protective against a subsequent more severe episode of ischaemia. These periods of mild ischaemia can be of the organ itself or of another organ in the body. For example ischaemia of the leg can protect the heart against ischaemia, so called “remote preconditioning”.  We have shown in animal and human models that remote preconditioning using a tourniquet placed around the leg for brief periods (similar in duration to when taking blood samples from children) reduces the amount of injury to heart muscle by 50% and also leads to improved heart and lung function. We have shown that remote preconditioning in a similar way protects the organs of a heterogeneous group of children undergoing cardiac surgery, resulting in better function of the heart and lungs and also a reduction of the inflammatory response to the heart-lung machine. This could potentially reduce the problems in looking after children after surgery and also reduce the amount of time spent on the intensive care unit. 
We intend to study a more uniform group of patients undergoing cardiac surgery in the neonatal period. All interventions will be performed during the period of routine general anaesthesia at the time of surgical repair. We will study the degree of organ injury induced by heart-lung bypass using standard intensive care parameters and equipment for measuring lung function. In addition, the degree heart muscle death and inflammation will be assessed by blood tests. Samples will be taken from indwelling catheters routinely placed at the time of surgery and not require additional venepuncture. Measurements will be made prior to surgery and also at set time intervals in the first 24 hours postoperatively to determine the evolution of effects.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Michael Cheung

Address

Department of Cardiology
Royal Children's Hospital
Parkville VIC 3052

Country

Australia

Phone

+61 3 93455718

Fax

michael.cheung@rch.org.au

Contact person for scientific queries

Name

Michael Cheung

Address

Department of Cardiology
Royal Children's Hospital
Parkville VIC 3052

Country

Australia

Phone

+61 3 93455718

Fax

michael.cheung@rch.org.au

No information has been provided regarding IPD availability

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.

Trial Review

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Documents added manually

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