Effect of postconditioning on cardiac protection in children undergoing tetralogy repair
| ISRCTN | ISRCTN36248338 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN36248338 |
| Protocol serial number | N/A |
| Sponsor | Xiang Ya Hospital (China) |
| Funder | Trial is internally funded by the Xiang Ya Hospital (China) |
- 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
Scientific
87 Xiangya Road
Changsha
410008
China
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, controlled study |
| Secondary study design | Randomised controlled trial |
| Scientific title | Effect of postconditioning on cardiac protection in children undergoing tetralogy repair |
| Study acronym | Postconditioning |
| Study objectives | Postconditioning 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) studied | 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 |
| Primary outcome measure(s) |
1. Postoperative Creatine Kinase - Myocardial Band (CKMB) |
| Key secondary outcome measure(s) |
1. Mortality |
| Completion date | 20/04/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Upper age limit | 14 Years |
| Sex | All |
| Target sample size at registration | 30 |
| Total final enrolment | 105 |
| Key inclusion criteria | 1. Patients with Tetralogy undergoing radical surgery 2. Less than 14 years old |
| Key exclusion criteria | 1. Tetralogy with pulmonary atresia 2. Emergency surgery 3. Palliative surgery |
| Date of first enrolment | 20/09/2006 |
| Date of final enrolment | 20/04/2007 |
Locations
Countries of recruitment
- China
Study participating centre
87 Xiangya Road
Changsha
410008
China
410008
China
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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.
