Study of Remote Ischemic Postconditioning

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2012-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Ischemia Bypass Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Remote ischemic postconditioning

Intervention Type PROCEDURE

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.

control

A blood cuff was around leg without inflation or deflation.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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Limb ischemic postconditioning

Eligibility Criteria

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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

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No