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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01313832
Enrollment
60
Registered
2011-03-14
Start date
2010-12-31
Completion date
2011-04-30
Last updated
2012-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Hypertension, Ventricular Septal Defect

Keywords

ventricular septal defect, remote ischemic preconditioning, pulmonary hypertension, infant with ventricular septal defect and pulmonary hypertension

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.

Interventions

OTHERremote ischemic preconditioning (RIPC)

RIPC will be performed by 5-min cycles of lower limb ischemia reperfusion using blood pressure cuff

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
No minimum to 1 Years
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

Design outcomes

Primary

MeasureTime frameDescription
troponin levelwithin the 1 day after operationtroponin 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.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 27, 2026