Myocardial Protection With Adenosine Preconditioning

Heart Defects, Congenital Clinical Trial

Official title:

Study of Myocardial Protection in Pediatric Cardiac Surgery With Adenosine Preconditioning

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00881686
• Other study ID #: xinzangwaike0002
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: April 14, 2009
• Last updated: April 14, 2009
• Start date: June 2008
• Est. completion date: December 2008

Study information

• Verified date: March 2009
• Source: Xijing Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 238
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 24 Months

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• adenosine
1.5mg/Kg adenosine will be administered intravenously before surgery

Locations

Country	Name	City	State
China	Institute of Cardiovascular Surgery, Xijing Hospital	Xi'an	Shannxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Outcome Measure: all cause mortality		within the first 30 days (plus or minus 3 days) after surgery	No
Secondary	The time of ICU stay		within the first 30 days (plus or minus 3 days) after surgery	No