Study of Remote Ischemic Postconditioning

Study Overview
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Brief Summary
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Cardiac surgery is associated with cardiac and cerebral injury because of ischemia/reperfusion in approximately one third of cases. Ischemic preconditioning (IPC), have been shown to reduce the extent of myocardial infarction (MI). As another ischemic conditioning, remote ischemic postconditioning, limits MI size in animal models. The purpose of this study is to evaluate the cardiac and cerebral protective effect of remote ischemic postconditioning in children undergoing cardiac surgery, as a single-center, randomized controlled trial.

Detailed Description
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Cardiac surgery is associated with Troponin release because of ischemia/reperfusion injury in approximately one third of cases. And I/R injury may also induce cerebral insult, even Postoperative Cognitive Dysfunction (POCD).Transient sublethal episodes of ischemia before a prolonged ischemia/reperfusion injury, known as ischemic preconditioning (IPC), have been shown to reduce the extent of myocardial infarction (MI).And remote ischemic postconditioning(RIPoC), as another ischemic condition, limits MI size in animal models. However, there are limited outcome to demonstrate protection from RIPoC during cardiac surgery. The purpose of this study is to investigate the cardiac and cerebral protective effect of remote ischemic postconditioning , as a single-center, randomized controlled trial.

Official Title
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A Randomized Control Trial of Effect of Remote Ischemic Postconditioning on Children Undergoing Cardiac Surgery

Conditions
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Ischemia, Bypass Complications

Intervention / Treatment
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* Procedure: Remote ischemic postconditioning


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All Children aged from 0 to 12 who are undergoing open congenital cardiac surgery. Exclusion Criteria: Simple atrial septal defect Bidirectional cavopulmonary shunt undergoing Fontan completion Chromosomal defects Airway or parenchymal lung disease Immunodeficiency Blood disorder

Ages Eligible for Study
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Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Remote ischemic postconditioning<br>At the time of reperfusion, remote ischaemic postconditioning will be induced by inflating a cuff around leg to 100 mmHg for 5 mins followed by 5 mins of reperfusion. This cycle will be repeated 3 times. | Procedure: Remote ischemic postconditioning<br>* At the time of reperfusion, remote ischaemic postconditioning will be induced by inflating a cuff around leg to 100 mmHg for 5 mins followed by 5 mins of reperfusion. This cycle will be repeated 3 times.<br>* Other names: Limb ischemic postconditioning;|
| No Intervention: control<br>A blood cuff was around leg without inflation or deflation. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cTnI,CK-MB concentration | The primary outcome is assessing whether cTnI or CK-MB concentration reduce at 24 hours after remote ischemic postconditioning. | 24h after Remote Ischemic Postconditioning | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NSE，S100β concentration | The secondary outcome is assessing whether NSE or S100-β concentration reduce at 24 hours after remote ischemic postcondioning. | 24 hours after Remote Ischemic Postconditioning |