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
Scientific
87 Xiangya Road
Changsha
410008
China
Study information
| Study design | Randomised, controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | 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 study start date | 20/09/2006 |
| Completion date | 20/04/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Upper age limit | 14 Years |
| Sex | Both |
| Target number of participants | 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
Sponsor information
Xiang Ya Hospital (China)
Hospital/treatment centre
Hospital/treatment centre
Central South University
No.87 Xiangya Road
Changsha
410078
China
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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.
