Back to resultsMyocardial Protection and Clinical Outcome in Patients Undergoing Tetralogy of Fallot Repair : A Randomized Study of Two Different Cardioplegia Technique (TOF)
Primary Purpose
Myocardial Protection in TOF Repair
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
blood cardioplegia
del nido cardioplegia
Sponsored by
About this trial
This is an interventional prevention trial for Myocardial Protection in TOF Repair focused on measuring tetralogy of fallot, cardioplegia
Eligibility Criteria
Inclusion Criteria:
- Tetralogy of fallot
Exclusion Criteria:
- TOF with absent pulmonary valve , TOF with pulmonary atresia
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
blood cardioplegia
del nido cardioplegia
Arm Description
these patients received blood cardioplegia
these patients received del nido cardioplegia
Outcomes
Primary Outcome Measures
inotropic score
Creatine kinase MB level baseline preoperative and postoperative 0, 6, 24, and 72 hours
resumption of spontaneous rhythm after aortic cross clamp off
Secondary Outcome Measures
duration of mechanical ventilation in hours
ICU stay
hospital mortality
echocardiographic assessment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02646254
Brief Title
Myocardial Protection and Clinical Outcome in Patients Undergoing Tetralogy of Fallot Repair : A Randomized Study of Two Different Cardioplegia Technique
Acronym
TOF
Official Title
MYOCARDIAL PROTECTION AND CLINICAL OUTCOME IN PATIENTS UNDERGOING TETRALOGY OF FALLOT REPAIR: A RANDOMIZED STUDY OF TWO CARDIOPLEGIC TECHNIQUES
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
SUNDER LAL NEGI
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Myocardial protection and clinical outcome in patients Undergoing tetralogy of fallot repair: a randomized study of Two cardioplegic techniques.
Detailed Description
Del Nido cardioplegia has not been used for myocardial protection and clinical outcome in patients undergoing tetralogy of Fallot repair, so the investigators hypothesized that a del Nido cardioplegia technique may be beneficial in the pediatric patients undergoing tetralogy of fallot repair.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Protection in TOF Repair
Keywords
tetralogy of fallot, cardioplegia
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
blood cardioplegia
Arm Type
Active Comparator
Arm Description
these patients received blood cardioplegia
Arm Title
del nido cardioplegia
Arm Type
Active Comparator
Arm Description
these patients received del nido cardioplegia
Intervention Type
Other
Intervention Name(s)
blood cardioplegia
Intervention Type
Other
Intervention Name(s)
del nido cardioplegia
Primary Outcome Measure Information:
Title
inotropic score
Time Frame
First 24 hours
Title
Creatine kinase MB level baseline preoperative and postoperative 0, 6, 24, and 72 hours
Time Frame
72hrs
Title
resumption of spontaneous rhythm after aortic cross clamp off
Time Frame
10 minutes
Secondary Outcome Measure Information:
Title
duration of mechanical ventilation in hours
Time Frame
48 hours
Title
ICU stay
Time Frame
7 days
Title
hospital mortality
Time Frame
30 days
Title
echocardiographic assessment
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Tetralogy of fallot
Exclusion Criteria:
TOF with absent pulmonary valve , TOF with pulmonary atresia
12. IPD Sharing Statement
Learn more about this trial
Myocardial Protection and Clinical Outcome in Patients Undergoing Tetralogy of Fallot Repair : A Randomized Study of Two Different Cardioplegia Technique
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