Back to resultsRemote Preconditioning and Myocardial Protection
Primary Purpose
Congenital Heart Disease
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Sevoflurane plus remote ischemic preconditioning
Total intravenous anesthesia plus remote ischemic preconditioning
Sponsored by
About this trial
This is an interventional prevention trial for Congenital Heart Disease focused on measuring remote ischemic preconditioning, sevoflurane, total intravenous anesthetic
Eligibility Criteria
Inclusion Criteria:
- Pediatric scheduled for cardiac surgery requiring the cardioplegic arrest and cardiopulmonary bypass
Exclusion Criteria:
- Previous cardiac surgery
- Urgent or emergent cases
- Patient with the following diseases diabetes mellitus ,hypertension ,renal failure, hepatic and pulmonary diseases
Sites / Locations
- Faculty of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group A
Group B
Arm Description
Sevoflurane plus remote ischemic preconditioning anesthesia will be induced and maintain with sevoflurane in addition to remote ischemic preconditioning which will be done after induction and before cardiopulmonary bypass by inflating the cuff of blood pressure above 200mmhg in the lower limb every 5 min for 3 cycles
anesthesia will be induced and maintain with total intravenous anesthesia (propofol, midazolam plus fentanyl) during plus remote ischemic preconditioning in addition to remote ischemic preconditioning which will be done after induction and before cardiopulmonary bypass by inflating the cuff of blood pressure above 200mmhg in the lower limb every 5 min for 3 cycles
Outcomes
Primary Outcome Measures
Troponin I levels
The investigators will obtain blood samples for troponin I level pre-Cardiopulmonary bypass, 6, 12 and 24 hours after the surgery. Troponin I levels, as a marker of myocardial ischemia, have been used in previous adult and pediatric studies on preconditioning.
Secondary Outcome Measures
Highest inotropic score during the first 24 hours after cardiac surgery
Inotrope score is a useful predictor of morbidity and mortality in children who undergo heart surgery.
The inotropic score is calculated as follows: 1 point is assigned for each mcg/kg/min of dopamine and dobutamine, and 10 points is assigned for each 0.1 mcg/kg/min of epinephrine, norepinephrine, and phenylephrine. Inotrope score is a useful predictor of morbidity and mortality in children who undergo heart surgery
Mortality at 30 days
Proportion of patients who dies within 30 days of their surgical repair
Cardiac function
Cardiac rhythm on return if it will be sinus rhythm or return with ventricular fibrillation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02877238
Brief Title
Remote Preconditioning and Myocardial Protection
Official Title
Protection by Remote Ischemic Preconditioning During Congenital Cardiac Defects Repair Surgery With Sevoflurane But Not Propofol -A Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
August 2016 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
May 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Remote ischemic preconditioning (RIPC) of the myocardium by limb ischemia/reperfusion may mitigate cardiac damage, but its interaction with the anesthetic regimen is unknown.
Detailed Description
The investigators will test if RIPC will be associated with differential effects depending on background anesthesia. Specifically, the investigators hypothesized that RIPC during sevoflurane anesthesia attenuates myocardial injury in patients undergoing congenital cardiac defects repair surgery and that effects may be different during propofol anesthesia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Disease
Keywords
remote ischemic preconditioning, sevoflurane, total intravenous anesthetic
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
91 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Active Comparator
Arm Description
Sevoflurane plus remote ischemic preconditioning anesthesia will be induced and maintain with sevoflurane in addition to remote ischemic preconditioning which will be done after induction and before cardiopulmonary bypass by inflating the cuff of blood pressure above 200mmhg in the lower limb every 5 min for 3 cycles
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
anesthesia will be induced and maintain with total intravenous anesthesia (propofol, midazolam plus fentanyl) during plus remote ischemic preconditioning in addition to remote ischemic preconditioning which will be done after induction and before cardiopulmonary bypass by inflating the cuff of blood pressure above 200mmhg in the lower limb every 5 min for 3 cycles
Intervention Type
Drug
Intervention Name(s)
Sevoflurane plus remote ischemic preconditioning
Other Intervention Name(s)
Group A
Intervention Description
Inhalational anesthesia (Sevoflurane) in addition to remote ischemic preconditioning
Intervention Type
Drug
Intervention Name(s)
Total intravenous anesthesia plus remote ischemic preconditioning
Other Intervention Name(s)
Group B
Intervention Description
Total intravenous anesthesia (propofol plus fentanyl) in addition to remote ischemic preconditioning
Primary Outcome Measure Information:
Title
Troponin I levels
Description
The investigators will obtain blood samples for troponin I level pre-Cardiopulmonary bypass, 6, 12 and 24 hours after the surgery. Troponin I levels, as a marker of myocardial ischemia, have been used in previous adult and pediatric studies on preconditioning.
Time Frame
within first 24 hours after cardiac surgery
Secondary Outcome Measure Information:
Title
Highest inotropic score during the first 24 hours after cardiac surgery
Description
Inotrope score is a useful predictor of morbidity and mortality in children who undergo heart surgery.
The inotropic score is calculated as follows: 1 point is assigned for each mcg/kg/min of dopamine and dobutamine, and 10 points is assigned for each 0.1 mcg/kg/min of epinephrine, norepinephrine, and phenylephrine. Inotrope score is a useful predictor of morbidity and mortality in children who undergo heart surgery
Time Frame
within first 24 hours after cardiac surgery
Title
Mortality at 30 days
Description
Proportion of patients who dies within 30 days of their surgical repair
Time Frame
30 days
Title
Cardiac function
Description
Cardiac rhythm on return if it will be sinus rhythm or return with ventricular fibrillation
Time Frame
within first 24 hours of cardiac surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pediatric scheduled for cardiac surgery requiring the cardioplegic arrest and cardiopulmonary bypass
Exclusion Criteria:
Previous cardiac surgery
Urgent or emergent cases
Patient with the following diseases diabetes mellitus ,hypertension ,renal failure, hepatic and pulmonary diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sayed K Abd-Elshafy, MD
Organizational Affiliation
Associate professor of anesthesia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine
City
Assiut
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Remote Preconditioning and Myocardial Protection
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