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

Tracking Information
First Received Date ^ICMJE	March 10, 2011
Last Updated Date	February 1, 2012
Start Date ^ICMJE	December 2010
Primary Completion Date	April 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 10, 2011)	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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01313832 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	The Effect of Remote Ischemic Preconditioning on the Ischemic Reperfusion Injury in Infants With Ventricular Septal Defect and Pulmonary Hypertension
Official Title ^ICMJE	Not Provided
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention
Condition ^ICMJE	Ventricular Septal Defect Pulmonary Hypertension
Intervention ^ICMJE	Other: remote ischemic preconditioning (RIPC) RIPC will be performed by 5-min cycles of lower limb ischemia reperfusion using blood pressure cuff
Study Arm (s)	Experimental: remote ischemic preconditioning Intervention: Other: remote ischemic preconditioning (RIPC)
Publications *	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. Epub 2011 Dec 8.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	60
Completion Date	April 2011
Primary Completion Date	April 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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	Both
Ages	up to 1 Year
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Korea, Republic of

Administrative Information
NCT Number ^ICMJE	NCT01313832
Other Study ID Numbers ^ICMJE	H-1012-120-345
Has Data Monitoring Committee	No
Responsible Party	Jin-Tae Kim, Seoul National University Hospital
Study Sponsor ^ICMJE	Seoul National University Hospital
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Seoul National University Hospital
Verification Date	February 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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