Myocardial Protection With Adenosine Preconditioning
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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 |
- Outcome Measure: all cause mortality [ Time Frame: within the first 30 days (plus or minus 3 days) after surgery ] [ Designated as safety issue: No ]
- 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 |
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 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 Cardiovascular Abnormalities Cardiovascular Diseases Heart Diseases Cardiomyopathies Myocardial Ischemia Vascular Diseases Postoperative Complications Pathologic Processes |
Adenosine Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anti-Arrhythmia Agents Cardiovascular Agents Vasodilator Agents |
ClinicalTrials.gov processed this record on June 17, 2013