Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Effect of postconditioning on cardiac protection in children undergoing tetralogy repair
Acronym
Postconditioning
Study hypothesis
Postconditioning can reduce the reperfusion injury of myocardium in open heart surgery.
Ethics approval
Approval gained on 06/05/2006 by Xiang Ya Hospital ethics committee.
Study design
Randomised, controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Infants and children with Tetralogy undergoing radical repair
Intervention
In the experimental group, the aorta is crossclamped for two cycles of 30 seconds clamping and 30 seconds unclamping onset of reperfusion after cardioplegic arrest.
In control group,the patients receive cold blood cardioplegic arrest alone without postconditioning.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
1. Postoperative Creatine Kinase - Myocardial Band (CKMB)
2. Cardiac Troponin I (cTnI)
3. Inotropic use
Secondary outcome measures
1. Mortality
2. Morbidity
3. Intensive Care Unit (ICU) stay
Overall trial start date
20/09/2006
Overall trial end date
20/04/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients with Tetralogy undergoing radical surgery
2. Less than 14 years old
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
30
Total final enrolment
105
Participant exclusion criteria
1. Tetralogy with pulmonary atresia
2. Emergency surgery
3. Palliative surgery
Recruitment start date
20/09/2006
Recruitment end date
20/04/2007
Locations
Countries of recruitment
China
Trial participating centre
87 Xiangya Road
Changsha
410008
China
Funders
Funder type
Hospital/treatment centre
Funder name
Trial is internally funded by the Xiang Ya Hospital (China)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2009 results in https://pubmed.ncbi.nlm.nih.gov/19374810/ (added 06/01/2021)