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

Seoul National University

Status: Completed

Conditions: Ventricular Septal Defect; Pulmonary Hypertension

Treatments: Other: remote ischemic preconditioning (RIPC)

Study type: Interventional

Funder types: Other

Identifiers

NCT01313832

H-1012-120-345

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: Under 1 year old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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60 participants in 1 patient group

remote ischemic preconditioning

Experimental group

Treatment:

Other: remote ischemic preconditioning (RIPC)