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Myocardial Protection With Adenosine Preconditioning

This study has been completed.
Information provided by:
Xijing Hospital Identifier:
First received: April 14, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
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.

Condition Intervention Phase
Heart Defects, Congenital Cardiac Surgical Procedures Myocardial Reperfusion Injury Adenosine Drug: adenosine Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of Myocardial Protection in Pediatric Cardiac Surgery With Adenosine Preconditioning

Resource links provided by NLM:

Further study details as provided by Xijing Hospital:

Primary Outcome Measures:
  • Outcome Measure: all cause mortality [ Time Frame: within the first 30 days (plus or minus 3 days) after surgery ]

Secondary Outcome Measures:
  • The time of ICU stay [ Time Frame: within the first 30 days (plus or minus 3 days) after surgery ]

Enrollment: 238
Study Start Date: June 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: adenosine
Adenosine will be administered intravenously before surgery
Drug: adenosine
1.5mg/Kg adenosine will be administered intravenously before surgery

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.

Ages Eligible for Study:   up to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00881686

China, Shannxi
Institute of Cardiovascular Surgery, Xijing Hospital
Xi'an, Shannxi, China, 710032
Sponsors and Collaborators
Xijing Hospital
Principal Investigator: Zhenxiao Jin, MD Xijing Hospital
  More Information

Responsible Party: Zhenxiao Jin, Xijing Hospital Identifier: NCT00881686     History of Changes
Other Study ID Numbers: xinzangwaike0002
Study First Received: April 14, 2009
Last Updated: April 14, 2009

Keywords provided by Xijing Hospital:
Ischemic Preconditioning, Myocardial

Additional relevant MeSH terms:
Reperfusion Injury
Congenital Abnormalities
Heart Defects, Congenital
Myocardial Reperfusion Injury
Vascular Diseases
Cardiovascular Diseases
Postoperative Complications
Pathologic Processes
Cardiovascular Abnormalities
Heart Diseases
Myocardial Ischemia
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Vasodilator Agents
Purinergic P1 Receptor Agonists
Purinergic Agonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action processed this record on August 18, 2017