Myocardial Protection With Adenosine Preconditioning

Phase 1

Completed

• Conditions: Heart Defects, Congenital; Cardiac Surgical Procedures; Myocardial Reperfusion Injury; Adenosine
• Interventions: Drug: adenosine

• Registration Number: NCT00881686
• Lead Sponsor: Xijing Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2008-06
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2009-03
• Study First Submitted: 2009-04-14
• Study First Submitted QC: 2009-04-14
• Last Update Submitted: 2009-04-14
• Study First Posted: 2009-04-15
• Last Update Posted: 2009-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 238

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
adenosine	adenosine	Adenosine will be administered intravenously before surgery

Primary Outcome Measures

Name	Time	Method
Outcome Measure: all cause mortality	within the first 30 days (plus or minus 3 days) after surgery

Secondary Outcome Measures

Name	Time	Method
The time of ICU stay	within the first 30 days (plus or minus 3 days) after surgery

Trial Locations

Locations (1)

Institute of Cardiovascular Surgery, Xijing Hospital; 🇨🇳 Xi'an, Shannxi, China