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

NCT01313832 | Completed

• 1 other identifier: H-1012-120-345
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

ventricular septal defect; remote ischemic preconditioning; pulmonary hypertension; infant with ventricular septal defect and pulmonary hypertension

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

remote ischemic preconditioning

EXPERIMENTAL

Other: remote ischemic preconditioning (RIPC)

Interventions

remote ischemic preconditioning (RIPC) OTHER

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

remote ischemic preconditioning

Eligibility Criteria

• Age: Up to 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• perimembranous or muscular outlet or muscular inlet ventricular septal defect
• pulmonary hypertension (+)
• infant (\<1 year)

You may not qualify if:

• subarterial ventricular defect
• chromosomal defect
• airway or parenchymal lung disease
• blood disorder
• anticipation of cardiac muscle resection

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Jin-Tae Kim

Seoul, South Korea

Location

Related Publications (1)

• 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.

  PMID: 22157844 DERIVED

MeSH Terms

Conditions

Heart Septal Defects, Ventricular; Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Heart Septal Defects; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: March 10, 2011
• First Posted: March 14, 2011
• Study Start: December 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: February 2, 2012

Record last verified: 2012-02

Locations

KR (1)