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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01313832
Recruitment Status : Completed
First Posted : March 14, 2011
Last Update Posted : February 2, 2012
Information provided by (Responsible Party):
Jin-Tae Kim, Seoul National University Hospital

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.

Condition or disease Intervention/treatment Phase
Ventricular Septal Defect Pulmonary Hypertension Other: remote ischemic preconditioning (RIPC) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Study Start Date : December 2010
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: remote ischemic preconditioning Other: remote ischemic preconditioning (RIPC)
RIPC will be performed by 5-min cycles of lower limb ischemia reperfusion using blood pressure cuff

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 1 Year   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01313832

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Korea, Republic of
Jin-Tae Kim
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Jin-Tae Kim, assistant professor, Seoul National University Hospital Identifier: NCT01313832     History of Changes
Other Study ID Numbers: H-1012-120-345
First Posted: March 14, 2011    Key Record Dates
Last Update Posted: February 2, 2012
Last Verified: February 2012
Keywords provided by Jin-Tae Kim, Seoul National University Hospital:
ventricular septal defect
remote ischemic preconditioning
pulmonary hypertension
infant with ventricular septal defect and pulmonary hypertension
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Heart Septal Defects
Heart Septal Defects, Ventricular
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Heart Defects, Congenital
Cardiovascular Abnormalities
Heart Diseases
Congenital Abnormalities