Study of Remote Ischemic Postconditioning
A Randomized Control Trial of Effect of Remote Ischemic Postconditioning on Children Undergoing Cardiac Surgery
1 other identifier
interventional
65
1 country
1
Brief Summary
Cardiac surgery is associated with cardiac and cerebral injury because of ischemia/reperfusion in approximately one third of cases. Ischemic preconditioning (IPC), have been shown to reduce the extent of myocardial infarction (MI). As another ischemic conditioning, remote ischemic postconditioning, limits MI size in animal models. The purpose of this study is to evaluate the cardiac and cerebral protective effect of remote ischemic postconditioning in children undergoing cardiac surgery, as a single-center, randomized controlled trial.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Aug 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 9, 2011
CompletedFirst Posted
Study publicly available on registry
October 12, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedJuly 24, 2013
July 1, 2013
1.2 years
October 9, 2011
July 22, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
cTnI,CK-MB concentration
The primary outcome is assessing whether cTnI or CK-MB concentration reduce at 24 hours after remote ischemic postconditioning.
24h after Remote Ischemic Postconditioning
Secondary Outcomes (1)
NSE，S100β concentration
24 hours after Remote Ischemic Postconditioning
Study Arms (2)
Remote ischemic postconditioning
EXPERIMENTALAt the time of reperfusion, remote ischaemic postconditioning will be induced by inflating a cuff around leg to 100 mmHg for 5 mins followed by 5 mins of reperfusion. This cycle will be repeated 3 times.
control
NO INTERVENTIONA blood cuff was around leg without inflation or deflation.
Interventions
At the time of reperfusion, remote ischaemic postconditioning will be induced by inflating a cuff around leg to 100 mmHg for 5 mins followed by 5 mins of reperfusion. This cycle will be repeated 3 times.
Eligibility Criteria
You may qualify if:
- All Children aged from 0 to 12 who are undergoing open congenital cardiac surgery.
You may not qualify if:
- Simple atrial septal defect
- Bidirectional cavopulmonary shunt undergoing Fontan completion
- Chromosomal defects
- Airway or parenchymal lung disease
- Immunodeficiency
- Blood disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xijing Hospitallead
Study Sites (1)
Xijing Hospital
Xi'an, Shaanxi, 710032, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Wang Qiang, doctor
Xijing Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- department of anesthesijology
Study Record Dates
First Submitted
October 9, 2011
First Posted
October 12, 2011
Study Start
August 1, 2011
Primary Completion
October 1, 2012
Study Completion
October 1, 2012
Last Updated
July 24, 2013
Record last verified: 2013-07