The Effect of Remote Ischemic Preconditioning on the Ischemic Reperfusion Injury in Infants With Ventricular Septal Defect and Pulmonary Hypertension

Study Overview
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Brief Summary
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Intraoperative myocardial and pulmonary protection is important for better outcome after cardiac surgery. Ischemic preconditioning is one of organ protective strategies against ischemia-reperfusion injury by applying brief ischemia to the target organ before a subsequent critical ischemia, and its effect has been confirmed. However, its clinical application is not easy because ischemic insult may aggravate the function of vulnerable organ. On the other hand, remote ischemic preconditioning (RIPC) is another protective approach by applying ischemia to other less vulnerable organ such as skeletal muscle before critical ischemia-reperfusion injury to heart. The effect of RIPC has been well demonstrated in adults and children. However, Little is known about the effect of remote ischemic precondition on the pediatric myocardium to ischemia and reperfusion injury. The effect of RIPC on the children remains to be further evaluated because the degree of ischemia-reperfusion injury is different according to age, cardiac pathology and cyanosis. In addition, the previous report on children dealt with a diverse range of congenital heart defects with a wide age range. The purpose of this study was to evaluate the effect of RIPC on myocardial and pulmonary protection in infants with pulmonary hypertension who need repair of simple ventricular septal defect.

Conditions
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Ventricular Septal Defect, Pulmonary Hypertension

Intervention / Treatment
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* Other: remote ischemic preconditioning (RIPC)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: perimembranous or muscular outlet or muscular inlet ventricular septal defect pulmonary hypertension (+) infant (<1 year) Exclusion Criteria: subarterial ventricular defect chromosomal defect airway or parenchymal lung disease blood disorder anticipation of cardiac muscle resection

Ages Eligible for Study
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Maximum Age: 1 Year

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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: remote ischemic preconditioning<br> | Other: remote ischemic preconditioning (RIPC)<br>* RIPC will be performed by 5-min cycles of lower limb ischemia reperfusion using blood pressure cuff<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| troponin level | troponin level will be checked 1, 6, 12 and 24 hours after operation. After making a graph for troponin-time, area under curve will be calculated. | within the 1 day after operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ventricular septal defect, remote ischemic preconditioning, pulmonary hypertension, infant with ventricular septal defect and pulmonary hypertension