Ischaemic Reperfusion Injury Clinical Trial
Official title:
Effect of Remote Ischaemic Preconditioning in Cardiac Dysfunction and End-organ Injury Following Cardiac Surgery With Cardiopulmonary Bypass in Children.
Surgical correction of congenital heart defects in children requires the utilization of
cardiopulmonary bypass, a technique that temporarily substitutes heart and lung functions
during surgery. During this process the patient´s circulation is controlled by a bypass
machine which provides several functions:
1. Controls the patient's blood flow by pumping of blood in the patient's body.
2. Controls the correct oxygen levels in the patient's blood.
3. Regulates the temperature and fluid level of the blood. This process triggers negative
responses in the heart and throughout the whole body, potentially resulting in injury
to the heart and other organs such as brain, kidneys and lungs.
Remote ischaemic preconditioning (RIPC) describes a procedure that could potentially reduce
the injury to heart muscle during cardiac surgery. The procedure consists of the inflation
of a blood pressure cuff on the child's leg for three 5 minute cycles. This process acts by
briefly reducing blood flow to the leg muscle, which will then activate the body´s own
protective mechanisms and thereby reduce heart injury.
Several animal studies have been used to help the understanding of the mechanisms behind
this process, and trials in human adults have showed optimistic results; however evidence
regarding the paediatric population is limited and necessary since children present
different basal profiles, risks and requirements.
The investigators propose a randomized clinical trial assessing the efficacy of RIPC to
provide protection against injury to the heart and other organs in children going through
cardiac surgery using CPB at the Royal Hospital for Sick Children. The research project will
have a translational approach, integrating basic molecular mechanisms to clinical outcome.
The investigators hope it will allow the understanding and utilisation of the patient´s own
protective mechanisms, reducing CPB-related injury and ultimately improving patient outcome.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Basic Science