Condition category
Circulatory System
Date applied
07/09/2006
Date assigned
15/11/2006
Last edited
06/01/2021
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Wanjun Luo

ORCID ID

Contact details

87 Xiangya Road
Changsha
410008
China

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

Sponsor information

Organisation

Xiang Ya Hospital (China)

Sponsor details

Central South University
No.87 Xiangya Road
Changsha
410078
China

Sponsor type

Hospital/treatment centre

Website

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)

Publication citations

Additional files

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.