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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jin-Tae Kim, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01313832
First received: March 10, 2011
Last updated: February 1, 2012
Last verified: February 2012
History of Changes
  Purpose

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 Intervention
Ventricular Septal Defect
Pulmonary Hypertension
 Other: remote ischemic preconditioning (RIPC)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • troponin level [ Time Frame: within the 1 day after operation ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 60
Study Start Date: December 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   up to 1 Year
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01313832

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

No publications provided by Seoul National University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Jin-Tae Kim, assistant professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01313832     History of Changes
Other Study ID Numbers: H-1012-120-345
Study First Received: March 10, 2011
Last Updated: February 1, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:
ventricular septal defect
remote ischemic preconditioning
pulmonary hypertension
infant with ventricular septal defect and pulmonary hypertension

Additional relevant MeSH terms:
Heart Septal Defects
Heart Septal Defects, Ventricular
Hypertension
Hypertension, Pulmonary
Reperfusion Injury
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
 Heart Diseases
Congenital Abnormalities
Vascular Diseases
Lung Diseases
Respiratory Tract Diseases
Postoperative Complications
Pathologic Processes

ClinicalTrials.gov processed this record on May 22, 2013