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Clinical Trials/NCT01313832
NCT01313832
Completed
N/A

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

Seoul National University Hospital1 site in 1 country60 target enrollmentDecember 2010

Overview

Phase
N/A
Intervention
Not specified
Conditions
Ventricular Septal Defect
Sponsor
Seoul National University Hospital
Enrollment
60
Locations
1
Primary Endpoint
troponin level
Status
Completed
Last Updated
14 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2010
End Date
April 2011
Last Updated
14 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jin-Tae Kim

assistant professor

Seoul National University Hospital

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

Outcomes

Primary Outcomes

troponin level

Time Frame: within the 1 day after operation

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.

Study Sites (1)

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