The Effect of Remote Ischemic Preconditioning on the Ischemic Reperfusion Injury in Infants With Ventricular Septal Defect and Pulmonary Hypertension
|ClinicalTrials.gov Identifier: NCT01313832|
Recruitment Status : Completed
First Posted : March 14, 2011
Last Update Posted : February 2, 2012
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Single (Outcomes Assessor)|
|Study Start Date :||December 2010|
|Actual Primary Completion Date :||April 2011|
|Actual Study Completion Date :||April 2011|
|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
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT01313832
|Korea, Republic of|
|Seoul, Korea, Republic of|