Myocardial Protection With Adenosine Preconditioning

This study has been completed.
Sponsor:
Information provided by:
Xijing Hospital
ClinicalTrials.gov Identifier:
NCT00881686
First received: April 14, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The time of ICU stay [ Time Frame: within the first 30 days (plus or minus 3 days) after surgery ] [ Designated as safety issue: No ]

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
Other Name: Adenosine

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.

  Eligibility

Ages Eligible for Study:   up to 24 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00881686

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

No publications provided

Responsible Party: Zhenxiao Jin, Xijing Hospital
ClinicalTrials.gov Identifier: NCT00881686     History of Changes
Other Study ID Numbers: xinzangwaike0002
Study First Received: April 14, 2009
Last Updated: April 14, 2009
Health Authority: China: Food and Drug Administration

Keywords provided by Xijing Hospital:
Ischemic Preconditioning, Myocardial
Adenosine

Additional relevant MeSH terms:
Congenital Abnormalities
Heart Defects, Congenital
Myocardial Reperfusion Injury
Reperfusion Injury
Cardiomyopathies
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Myocardial Ischemia
Pathologic Processes
Postoperative Complications
Vascular Diseases
Adenosine
Analgesics
Anti-Arrhythmia Agents
Cardiovascular Agents
Central Nervous System Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on October 21, 2014