Myocardial Protection With Adenosine Preconditioning

Study of Myocardial Protection in Pediatric Cardiac Surgery With Adenosine Preconditioning

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00881686

Enrollment

238

Registered

2009-04-15

Start date

2008-06-30

Completion date

2008-12-31

Last updated

2009-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Ischemic Preconditioning, Myocardial, Adenosine

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.

Interventions

DRUGadenosine

1.5mg/Kg adenosine will be administered intravenously before surgery

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

1 Days to 24 Months

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

Design outcomes

Primary

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

Secondary

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026