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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 1507 0
Condition category
Condition code
Cardiovascular 1605 1605 0 0
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] 1490 0
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] 2214 0
Postoperative levels of troponin I will be measured from blood samples
Timepoint [1] 2214 0
Blood samples taken immediately preoperatively and then at 3, 6 and 24 hours postoperatively.
Secondary outcome [1] 3858 0
Cardiac output, lung function, systemic inflammatory response.
Timepoint [1] 3858 0
Each of these will be assessed at 3, 6 and 24 hours postoperatively.
Secondary outcome [2] 3859 0
Inflammatory response in the form of blood levels of TNF-alpha.
Timepoint [2] 3859 0
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?
No
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
68
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1749 0
Government body
Name [1] 1749 0
National Heart Foundation
Country [1] 1749 0
Australia
Funding source category [2] 3087 0
Charities/Societies/Foundations
Name [2] 3087 0
Heartkids and Manchester Unity
Country [2] 3087 0
Australia
Primary sponsor type
Individual
Name
Michael Cheung
Address
Royal Childrens Hospital, Parkville, Victoria 3052
Country
Australia
Secondary sponsor category [1] 1546 0
Individual
Name [1] 1546 0
Lara Shekerdemian
Address [1] 1546 0
Royal Childrens Hospital, Parkville, VIC 3052
Country [1] 1546 0
Australia
Secondary sponsor category [2] 1547 0
Individual
Name [2] 1547 0
Ian Mackenzie
Address [2] 1547 0
Royal Childrens Hospital, Parkville, VIC 3052
Country [2] 1547 0
Australia
Secondary sponsor category [3] 1548 0
Individual
Name [3] 1548 0
Yves D'Udekem
Address [3] 1548 0
Royal Childrens Hospital, Parkville, VIC 3052
Country [3] 1548 0
Australia
Secondary sponsor category [4] 1549 0
Individual
Name [4] 1549 0
Steve Horten
Address [4] 1549 0
Royal Childrens Hospital, Parkville, VIC 3052
Country [4] 1549 0
Australia
Secondary sponsor category [5] 1550 0
Individual
Name [5] 1550 0
Polly Hardy
Address [5] 1550 0
Royal Childrens Hospital, Parkville, VIC 3052
Country [5] 1550 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3246 0
Ethics and Human Research Committee of the Royal Childrens Hospital Melbourne
Ethics committee address [1] 3246 0
Ethics committee country [1] 3246 0
Australia
Date submitted for ethics approval [1] 3246 0
01/05/2006
Approval date [1] 3246 0
14/03/2007
Ethics approval number [1] 3246 0
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 27424 0
Address 27424 0
Country 27424 0
Phone 27424 0
Fax 27424 0
Email 27424 0
Contact person for public queries
Name 10679 0
Michael Cheung
Address 10679 0
Department of Cardiology
Royal Children's Hospital
Parkville VIC 3052
Country 10679 0
Australia
Phone 10679 0
+61 3 93455718
Fax 10679 0
Email 10679 0
[email protected]
Contact person for scientific queries
Name 1607 0
Michael Cheung
Address 1607 0
Department of Cardiology
Royal Children's Hospital
Parkville VIC 3052
Country 1607 0
Australia
Phone 1607 0
+61 3 93455718
Fax 1607 0
Email 1607 0
[email protected]

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
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