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

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Brief Title

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


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.
    



Study Type

Interventional


Primary Outcome

troponin level


Condition

Ventricular Septal Defect

Intervention

remote ischemic preconditioning (RIPC)

Study Arms / Comparison Groups

 remote ischemic preconditioning
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

60

Start Date

December 2010

Completion Date

April 2011

Primary Completion Date

April 2011

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
      

Gender

All

Ages

N/A - 1 Year

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

Korea, Republic of

Location Countries

Korea, Republic of

Administrative Informations


NCT ID

NCT01313832

Organization ID

H-1012-120-345


Responsible Party

Principal Investigator

Study Sponsor

Seoul National University Hospital


Study Sponsor

, , 


Verification Date

February 2012