Study of Remote Ischemic Postconditioning
Primary Purpose
Ischemia, Bypass Complications
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Remote ischemic postconditioning
Sponsored by

About this trial
This is an interventional prevention trial for Ischemia
Eligibility Criteria
Inclusion Criteria:
- All Children aged from 0 to 12 who are undergoing open congenital cardiac surgery.
Exclusion Criteria:
- Simple atrial septal defect
- Bidirectional cavopulmonary shunt undergoing Fontan completion
- Chromosomal defects
- Airway or parenchymal lung disease
- Immunodeficiency
- Blood disorder
Sites / Locations
- Xijing Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Remote ischemic postconditioning
control
Arm Description
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.
A blood cuff was around leg without inflation or deflation.
Outcomes
Primary Outcome Measures
cTnI,CK-MB concentration
The primary outcome is assessing whether cTnI or CK-MB concentration reduce at 24 hours after remote ischemic postconditioning.
Secondary Outcome Measures
NSE,S100β concentration
The secondary outcome is assessing whether NSE or S100-β concentration reduce at 24 hours after remote ischemic postcondioning.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01450475
Brief Title
Study of Remote Ischemic Postconditioning
Official Title
A Randomized Control Trial of Effect of Remote Ischemic Postconditioning on Children Undergoing Cardiac Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xijing Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Cardiac surgery is associated with Troponin release because of ischemia/reperfusion injury in approximately one third of cases. And I/R injury may also induce cerebral insult, even Postoperative Cognitive Dysfunction (POCD).Transient sublethal episodes of ischemia before a prolonged ischemia/reperfusion injury, known as ischemic preconditioning (IPC), have been shown to reduce the extent of myocardial infarction (MI).And remote ischemic postconditioning(RIPoC), as another ischemic condition, limits MI size in animal models.
However, there are limited outcome to demonstrate protection from RIPoC during cardiac surgery. The purpose of this study is to investigate the cardiac and cerebral protective effect of remote ischemic postconditioning , as a single-center, randomized controlled trial.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemia, Bypass Complications
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Remote ischemic postconditioning
Arm Type
Experimental
Arm Description
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.
Arm Title
control
Arm Type
No Intervention
Arm Description
A blood cuff was around leg without inflation or deflation.
Intervention Type
Procedure
Intervention Name(s)
Remote ischemic postconditioning
Other Intervention Name(s)
Limb ischemic postconditioning
Intervention Description
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.
Primary Outcome Measure Information:
Title
cTnI,CK-MB concentration
Description
The primary outcome is assessing whether cTnI or CK-MB concentration reduce at 24 hours after remote ischemic postconditioning.
Time Frame
24h after Remote Ischemic Postconditioning
Secondary Outcome Measure Information:
Title
NSE,S100β concentration
Description
The secondary outcome is assessing whether NSE or S100-β concentration reduce at 24 hours after remote ischemic postcondioning.
Time Frame
24 hours after Remote Ischemic Postconditioning
10. Eligibility
Sex
All
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All Children aged from 0 to 12 who are undergoing open congenital cardiac surgery.
Exclusion Criteria:
Simple atrial septal defect
Bidirectional cavopulmonary shunt undergoing Fontan completion
Chromosomal defects
Airway or parenchymal lung disease
Immunodeficiency
Blood disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wang Qiang, doctor
Organizational Affiliation
Xijing Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Xijing Hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
12. IPD Sharing Statement
Learn more about this trial
Study of Remote Ischemic Postconditioning
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