Study of Remote Ischemic Postconditioning

Xijing Hospital65 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Ischemia Bypass Complications

Interventions

Remote ischemic postconditioningPROCEDURE

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.

Eligibility

Sex: ALLMax age: 12 Years

Medical Language ↔ Plain English

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

Locations (1)

Xijing Hospital

Xi'an, Shaanxi, China

Outcomes

Primary Outcomes

cTnI,CK-MB concentration

The primary outcome is assessing whether cTnI or CK-MB concentration reduce at 24 hours after remote ischemic postconditioning.

Time frame: 24h after Remote Ischemic Postconditioning

Secondary Outcomes

NSE，S100β concentration

The secondary outcome is assessing whether NSE or S100-β concentration reduce at 24 hours after remote ischemic postcondioning.

Time frame: 24 hours after Remote Ischemic Postconditioning

Data from ClinicalTrials.gov

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