Myocardial Protection With Adenosine Preconditioning

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/PHASE2

Total Enrollment

238 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2008-12-31

Brief Summary

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Adenosine has been proved to be an important mediator of myocardial protection induced by ischemic preconditioning. The hypothesis of this study is that adenosine preconditioning can provide additional myocardial protection in the setting of pediatric open heart surgery with cardioplegia and cardiopulmonary bypass.

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Detailed Description

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Adenosine has been used for diagnosis and treatment of cardiovascular diseases for many years. New progresses in myocardial protection in the settings of acute myocardial infarction treatment put forward the its clinical use to a broader field. But the safety and effectiveness of its use in myocardial protection in the setting of open heart surgery has not been investigated intensively. Our primary results suggested that adenosine preconditioning could decrease the release of myocardial serum markers, such as cTnI. This study will focus on the safety and effectiveness of adenosine in the field of pediatric myocardial protection during surgery repair of congenital heart defects with CPB and cardioplegia.

Conditions

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Heart Defects, Congenital Cardiac Surgical Procedures Myocardial Reperfusion Injury Adenosine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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adenosine

Adenosine will be administered intravenously before surgery

Group Type EXPERIMENTAL

adenosine

Intervention Type DRUG

1.5mg/Kg adenosine will be administered intravenously before surgery

Interventions

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adenosine

1.5mg/Kg adenosine will be administered intravenously before surgery

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of congenital heart defects eligible for surgery treatment under cardiopulmonary bypass and cardioplegia
* Body weight less than or equals to 10kg