RecruitingPhase 1ACTRN12607000004460

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


Sponsor

Michael Cheung

Enrollment

68 participants

Start Date

Jan 2, 2008

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 1 DaysMax Age: 28 Dayss

Plain Language Summary

Simplified for easier understanding

This study is for newborn babies who need open heart surgery to fix a heart defect they were born with. Heart surgery using the heart-lung bypass machine can damage organs because blood flow is temporarily reduced. This trial tests a technique called 'remote preconditioning' — where a soft cuff is placed around the baby's leg and briefly inflated a few times — to see if this simple step can protect the heart during surgery and reduce damage. This is similar to having a blood pressure cuff on the arm, and it is done while the baby is already under anaesthesia for the operation. You may be eligible if: - Your baby is a newborn (up to 28 days old) - Your baby needs open heart surgery for a congenital heart defect - Your baby is having an arterial switch procedure or Norwood procedure You may NOT be eligible if: - Your baby has a chromosomal condition (such as Down syndrome) - Your baby has a congenital lung abnormality - Your baby has a blood disorder - Your baby is older than 28 days Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Preconditioning as a method of myocardial protection at the time of repair of congenital heart disease.

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.


Locations(1)

Australia

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ACTRN12607000004460