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Myocardial Protection With Adenosine Preconditioning

Primary Purpose

Heart Defects, Congenital, Cardiac Surgical Procedures, Myocardial Reperfusion Injury

Status

Completed

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

adenosine

About this trial

This is an interventional treatment trial for Heart Defects, Congenital focused on measuring Ischemic Preconditioning, Myocardial, Adenosine

Eligibility Criteria

1 Day - 24 Months (Child)All SexesDoes not accept 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

Sites / Locations

Institute of Cardiovascular Surgery, Xijing Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

adenosine

Arm Description

Adenosine will be administered intravenously before surgery

Outcomes

Primary Outcome Measures

Outcome Measure: all cause mortality

Secondary Outcome Measures

The time of ICU stay

Full Information

NCT ID

NCT00881686

First Posted

April 14, 2009

Last Updated

April 14, 2009

Sponsor

Xijing Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00881686

Brief Title

Myocardial Protection With Adenosine Preconditioning

Official Title

Study of Myocardial Protection in Pediatric Cardiac Surgery With Adenosine Preconditioning

Study Type

Interventional

2. Study Status

Record Verification Date

March 2009

Overall Recruitment Status

Completed

Study Start Date

June 2008 (undefined)

Primary Completion Date

December 2008 (Actual)

Study Completion Date

December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Xijing Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Defects, Congenital, Cardiac Surgical Procedures, Myocardial Reperfusion Injury, Adenosine

Keywords

Ischemic Preconditioning, Myocardial, Adenosine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

238 (Actual)

8. Arms, Groups, and Interventions

Arm Title

adenosine

Arm Type

Experimental

Arm Description

Adenosine will be administered intravenously before surgery

Intervention Type

Drug

Intervention Name(s)

adenosine

Intervention Description

1.5mg/Kg adenosine will be administered intravenously before surgery

Primary Outcome Measure Information:

Title

Outcome Measure: all cause mortality

Time Frame

within the first 30 days (plus or minus 3 days) after surgery

Secondary Outcome Measure Information:

Title

The time of ICU stay

Time Frame

within the first 30 days (plus or minus 3 days) after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Day

Maximum Age & Unit of Time

24 Months

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zhenxiao Jin, MD

Organizational Affiliation

Xijing Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Institute of Cardiovascular Surgery, Xijing Hospital

City

Xi'an

State/Province

Shannxi

ZIP/Postal Code

710032

Country

China

12. IPD Sharing Statement

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Myocardial Protection With Adenosine Preconditioning

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