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Myocardial Protection With Adenosine Preconditioning

A

Air Force Military Medical University of People's Liberation Army

Status and phase

Completed
Phase 2
Phase 1

Conditions

Heart Defects, Congenital
Adenosine
Myocardial Reperfusion Injury
Cardiac Surgical Procedures

Treatments

Drug: adenosine

Study type

Interventional

Funder types

Other

Identifiers

NCT00881686
xinzangwaike0002

Details and patient eligibility

About

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.

Full description

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.

Enrollment

238 patients

Sex

All

Ages

1 day to 24 months old

Volunteers

No Healthy Volunteers

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

Exclusion criteria

  • Cardiac surgery is performed without cardiopulmonary or cardioplegia
  • Body weight more than 10Kg

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

238 participants in 1 patient group

adenosine
Experimental group
Description:
Adenosine will be administered intravenously before surgery
Treatment:
Drug: adenosine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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