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

NCT ID: NCT01313832

Last Updated: 2012-02-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2011-04-30

Brief Summary

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

Ventricular Septal Defect; Pulmonary Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

remote ischemic preconditioning

Group Type: EXPERIMENTAL

remote ischemic preconditioning (RIPC)

Intervention Type: OTHER

RIPC will be performed by 5-min cycles of lower limb ischemia reperfusion using blood pressure cuff

Interventions

remote ischemic preconditioning (RIPC)

RIPC will be performed by 5-min cycles of lower limb ischemia reperfusion using blood pressure cuff

Intervention Type: OTHER

Eligibility Criteria

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

• Maximum Eligible Age: 1 Year
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jin-Tae Kim

assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Jin-Tae Kim

Seoul, , South Korea

Countries

South Korea

References

Lee JH, Park YH, Byon HJ, Kim HS, Kim CS, Kim JT. Effect of remote ischaemic preconditioning on ischaemic-reperfusion injury in pulmonary hypertensive infants receiving ventricular septal defect repair. Br J Anaesth. 2012 Feb;108(2):223-8. doi: 10.1093/bja/aer388. Epub 2011 Dec 8.

Reference Type: DERIVED

PMID: 22157844 (View on PubMed)

Other Identifiers

H-1012-120-345

Identifier Type: -

Identifier Source: org_study_id