Back to resultsEffect of Remote Ischemic Preconditioning on Children Undergoing Cardiac Surgery
Primary Purpose
Cyanosis
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
RIPC (remote ischemic preconditioning)
Sponsored by
About this trial
This is an interventional prevention trial for Cyanosis focused on measuring troponin, open heart surgery, children
Eligibility Criteria
Inclusion Criteria:
- open heart surgery under cardiopulmonary bypass: ventricular septal defect, tetralogy of Fallot
Exclusion Criteria:
- chromosomal defect
- airway and parenchymal lung disease blood disorder
- isolated atrail septal defect
- immunodeficiency
Sites / Locations
- Seoul National University Hospital
- Seoul national university hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
remote ischemic preconditioning
Arm Description
Outcomes
Primary Outcome Measures
troponin level
troponin level will be checked 1, 6, 12 and 24 hours after operation. Ater making a graph (troponin-time), area under the curve will bw calculated.
Secondary Outcome Measures
Full Information
NCT ID
NCT01311310
First Posted
September 20, 2009
Last Updated
April 30, 2012
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01311310
Brief Title
Effect of Remote Ischemic Preconditioning on Children Undergoing Cardiac Surgery
Official Title
Effect of Remote Ischemic Preconditioning on Children Undergoing Cardiac Surgery: Implication of Preoperative Cyanosis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is conducted in order to evaluate the effect of remote ischemic preconditioning on children undergoing cardiac surgery, especially focusing on possible differences according to preoperative cyanosis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cyanosis
Keywords
troponin, open heart surgery, children
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
remote ischemic preconditioning
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
RIPC (remote ischemic preconditioning)
Intervention Description
RIPC will be performed by four 5-min cycles of lower limb ischemia and 5 in reperfusion using blood-pressure cuff inflated to a pressure 15 mmHg greater than the systolic arterial pressure measured via arterial line.
Primary Outcome Measure Information:
Title
troponin level
Description
troponin level will be checked 1, 6, 12 and 24 hours after operation. Ater making a graph (troponin-time), area under the curve will bw calculated.
Time Frame
within the 1 day after operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
open heart surgery under cardiopulmonary bypass: ventricular septal defect, tetralogy of Fallot
Exclusion Criteria:
chromosomal defect
airway and parenchymal lung disease blood disorder
isolated atrail septal defect
immunodeficiency
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Seoul national university hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
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Effect of Remote Ischemic Preconditioning on Children Undergoing Cardiac Surgery
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