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

March 10, 2011
February 1, 2012
December 2010
April 2011   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01313832 on ClinicalTrials.gov Archive Site
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The Effect of Remote Ischemic Preconditioning on the Ischemic Reperfusion Injury in Infants With Ventricular Septal Defect and Pulmonary Hypertension
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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.

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Interventional
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
  • Ventricular Septal Defect
  • Pulmonary Hypertension
Other: remote ischemic preconditioning (RIPC)
RIPC will be performed by 5-min cycles of lower limb ischemia reperfusion using blood pressure cuff
Experimental: remote ischemic preconditioning
Intervention: Other: remote ischemic preconditioning (RIPC)
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
April 2011
April 2011   (final data collection date for primary outcome measure)

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
Both
up to 1 Year
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01313832
H-1012-120-345
No
Jin-Tae Kim, Seoul National University Hospital
Seoul National University Hospital
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Seoul National University Hospital
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP