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Trial record 9 of 1197 for:    adenosine

Myocardial Protection With Adenosine Preconditioning

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ClinicalTrials.gov Identifier: NCT00881686
Recruitment Status : Completed
First Posted : April 15, 2009
Last Update Posted : April 15, 2009
Sponsor:
Information provided by:
Xijing Hospital

Tracking Information
First Submitted Date  ICMJE April 14, 2009
First Posted Date  ICMJE April 15, 2009
Last Update Posted Date April 15, 2009
Study Start Date  ICMJE June 2008
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 14, 2009)
Outcome Measure: all cause mortality [ Time Frame: within the first 30 days (plus or minus 3 days) after surgery ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 14, 2009)
The time of ICU stay [ Time Frame: within the first 30 days (plus or minus 3 days) after surgery ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Myocardial Protection With Adenosine Preconditioning
Official Title  ICMJE Study of Myocardial Protection in Pediatric Cardiac Surgery With Adenosine Preconditioning
Brief 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Heart Defects, Congenital
  • Cardiac Surgical Procedures
  • Myocardial Reperfusion Injury
  • Adenosine
Intervention  ICMJE Drug: adenosine
1.5mg/Kg adenosine will be administered intravenously before surgery
Study Arms  ICMJE Experimental: adenosine
Adenosine will be administered intravenously before surgery
Intervention: Drug: adenosine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 14, 2009)
238
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2008
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 24 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00881686
Other Study ID Numbers  ICMJE xinzangwaike0002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Zhenxiao Jin, Xijing Hospital
Study Sponsor  ICMJE Xijing Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Zhenxiao Jin, MD Xijing Hospital
PRS Account Xijing Hospital
Verification Date March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP