Skip to main content
OpenTrials
Completed

NCT Number: NCT00881686

Myocardial Protection With Adenosine Preconditioning

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Heart Defects, Congenital Adenosine Cardiac Surgical Procedures Cardiomyopathies Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Diseases Myocardial Ischemia Myocardial Reperfusion Injury Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Reperfusion Injury Vascular Diseases

Age range

1 day–24 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Institute of Cardiovascular Surgery, Xijing Hospital

Xi'an, Shannxi, 710032, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adenosine

Drug

1.5mg/Kg adenosine will be administered intravenously before surgery

Primary outcomes

  1. Outcome Measure: all cause mortality

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

Secondary outcomes

  1. The time of ICU stay

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

Sponsors and collaborators

Lead sponsor

Xijing Hospital

Other

Registry information

Official study title

Study of Myocardial Protection in Pediatric Cardiac Surgery With Adenosine Preconditioning

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Apr 15, 2009
Registry last updated
Apr 15, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.