Study of Remote Ischemic Postconditioning

Overview

Cardiac surgery is associated with cardiac and cerebral injury because of ischemia/reperfusion in approximately one third of cases. Ischemic preconditioning (IPC), have been shown to reduce the extent of myocardial infarction (MI). As another ischemic conditioning, remote ischemic postconditioning, limits MI size in animal models. The purpose of this study is to evaluate the cardiac and cerebral protective effect of remote ischemic postconditioning in children undergoing cardiac surgery, as a single-center, randomized controlled trial.

Full Title of Study: “A Randomized Control Trial of Effect of Remote Ischemic Postconditioning on Children Undergoing Cardiac Surgery”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Investigator, Outcomes Assessor)
  • Study Primary Completion Date: October 2012

Detailed Description

Cardiac surgery is associated with Troponin release because of ischemia/reperfusion injury in approximately one third of cases. And I/R injury may also induce cerebral insult, even Postoperative Cognitive Dysfunction (POCD).Transient sublethal episodes of ischemia before a prolonged ischemia/reperfusion injury, known as ischemic preconditioning (IPC), have been shown to reduce the extent of myocardial infarction (MI).And remote ischemic postconditioning(RIPoC), as another ischemic condition, limits MI size in animal models.

However, there are limited outcome to demonstrate protection from RIPoC during cardiac surgery. The purpose of this study is to investigate the cardiac and cerebral protective effect of remote ischemic postconditioning , as a single-center, randomized controlled trial.

Interventions

  • Procedure: Remote ischemic postconditioning
    • At the time of reperfusion, remote ischaemic postconditioning will be induced by inflating a cuff around leg to 100 mmHg for 5 mins followed by 5 mins of reperfusion. This cycle will be repeated 3 times.

Arms, Groups and Cohorts

  • Experimental: Remote ischemic postconditioning
    • At the time of reperfusion, remote ischaemic postconditioning will be induced by inflating a cuff around leg to 100 mmHg for 5 mins followed by 5 mins of reperfusion. This cycle will be repeated 3 times.
  • No Intervention: control
    • A blood cuff was around leg without inflation or deflation.

Clinical Trial Outcome Measures

Primary Measures

  • cTnI,CK-MB concentration
    • Time Frame: 24h after Remote Ischemic Postconditioning
    • The primary outcome is assessing whether cTnI or CK-MB concentration reduce at 24 hours after remote ischemic postconditioning.

Secondary Measures

  • NSE,S100β concentration
    • Time Frame: 24 hours after Remote Ischemic Postconditioning
    • The secondary outcome is assessing whether NSE or S100-β concentration reduce at 24 hours after remote ischemic postcondioning.

Participating in This Clinical Trial

Inclusion Criteria

  • All Children aged from 0 to 12 who are undergoing open congenital cardiac surgery.

Exclusion Criteria

  • Simple atrial septal defect
  • Bidirectional cavopulmonary shunt undergoing Fontan completion
  • Chromosomal defects
  • Airway or parenchymal lung disease
  • Immunodeficiency
  • Blood disorder

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 12 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Xijing Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: wangqiang, department of anesthesijology – Xijing Hospital
  • Overall Official(s)
    • Wang Qiang, doctor, Study Director, Xijing Hospital

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