Effect of postconditioning on cardiac protection in children undergoing tetralogy repair

ISRCTN ISRCTN36248338
DOI https://doi.org/10.1186/ISRCTN36248338
Secondary identifying numbers N/A
Submission date
07/09/2006
Registration date
15/11/2006
Last edited
06/01/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Wanjun Luo
Scientific

87 Xiangya Road
Changsha
410008
China

Study information

Study designRandomised, controlled study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleEffect of postconditioning on cardiac protection in children undergoing tetralogy repair
Study acronymPostconditioning
Study objectivesPostconditioning can reduce the reperfusion injury of myocardium in open heart surgery.
Ethics approval(s)Approval gained on 06/05/2006 by Xiang Ya Hospital ethics committee.
Health condition(s) or problem(s) studiedInfants and children with Tetralogy undergoing radical repair
InterventionIn 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 typeOther
Primary outcome measure1. Postoperative Creatine Kinase - Myocardial Band (CKMB)
2. Cardiac Troponin I (cTnI)
3. Inotropic use
Secondary outcome measures1. Mortality
2. Morbidity
3. Intensive Care Unit (ICU) stay
Overall study start date20/09/2006
Completion date20/04/2007

Eligibility

Participant type(s)Patient
Age groupChild
Upper age limit14 Years
SexBoth
Target number of participants30
Total final enrolment105
Key inclusion criteria1. Patients with Tetralogy undergoing radical surgery
2. Less than 14 years old
Key exclusion criteria1. Tetralogy with pulmonary atresia
2. Emergency surgery
3. Palliative surgery
Date of first enrolment20/09/2006
Date of final enrolment20/04/2007

Locations

Countries of recruitment

  • China

Study participating centre

87 Xiangya Road
Changsha
410008
China

Sponsor information

Xiang Ya Hospital (China)
Hospital/treatment centre

Central South University
No.87 Xiangya Road
Changsha
410078
China

ROR logo "ROR" https://ror.org/05c1yfj14

Funders

Funder type

Hospital/treatment centre

Trial is internally funded by the Xiang Ya Hospital (China)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/04/2009 06/01/2021 Yes No

Editorial Notes

06/01/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.