Impact of Variable Types of Preconditioning Upon the Inotrope Score in Adult Patients, Undergoing Cardiac Surgery
Primary Purpose
Myocardial Ischemia
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
A pharmacologic cardiac preconditioning (Sevoflurane)
B ischeamic preconditioning
Sponsored by
About this trial
This is an interventional supportive care trial for Myocardial Ischemia focused on measuring Myocardial Preconditioning, inotropic score
Eligibility Criteria
Inclusion Criteria:
- 18-60 years old
- American Society of Anesthesiologists physical status II and III
- Patients scheduled for open heart surgery
Exclusion Criteria:
- Emergency surgery
- Clinically significant kidney or liver disease
- Patients allergic to local anesthetic
- Patients with prolonged cardiopulmonary bypass time (>120 min)
- Patients required intra-aortic balloon pump
- Postoperative hemodynamic instability (including the occurrence of serious arrhythmia) or bleeding that required surgical re-exploration
Sites / Locations
- Emad Zarief Kamel Said
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
A pharmacologic cardiac preconditioning
B ischeamic preconditioning
Arm Description
Sevoflurane as a pharmacologic preconditioner for the heart
ischemic preconditioning by inflation the cuff of blood pressure
Outcomes
Primary Outcome Measures
Highest inotropic score
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02715869
Brief Title
Impact of Variable Types of Preconditioning Upon the Inotrope Score in Adult Patients, Undergoing Cardiac Surgery
Official Title
Impact of Variable Types of Preconditioning Upon the Inotrope Score in Adult Patients, Undergoing Cardiac Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
June 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
Preconditioning (PC) of the heart occurs when brief exposure to a stimulus protects the heart from subsequent ischemia. PC stimulus may be (ischemic ; pharmacologic or Physical).
Detailed Description
Preconditioning (PC) of the heart occurs when brief exposure to a stimulus protects the heart from subsequent ischemia. PC stimulus may be ( ischemic ; pharmacologic or Physical)
Pharmacological PC may be induced by variable agents e.g. (Sevoflurane ;isoflorane, opioids etc)
Ischemic PC includes local; remote and the idea is temporary interruption of blood supply to the organ so that liberation of protective mediators occurs. The liberated mediators have favorable effects not only upon the myocardium, but it extend to protect other organs against inflammatory activation; ischemia reperfusion injury
Inotropic score (IS) is already an evident predictor of postoperative cardiac morbidity and mortality
Aim of the work:
Is to validate the impact of Sevoflurane versus ischemic & Sevoflurane PC upon postoperative inotropic score in adult patient undergoing open heart surgery
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Ischemia
Keywords
Myocardial Preconditioning, inotropic score
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A pharmacologic cardiac preconditioning
Arm Type
Active Comparator
Arm Description
Sevoflurane as a pharmacologic preconditioner for the heart
Arm Title
B ischeamic preconditioning
Arm Type
Active Comparator
Arm Description
ischemic preconditioning by inflation the cuff of blood pressure
Intervention Type
Drug
Intervention Name(s)
A pharmacologic cardiac preconditioning (Sevoflurane)
Intervention Description
A Patients are anaesthetized by Sevoflurane more than 1 mac.
Intervention Type
Procedure
Intervention Name(s)
B ischeamic preconditioning
Intervention Description
B ischemic preconditioning will be done after induction and before cardiopulmonary bypass by inflation the cuff of blood pressure above 200mmhg in the lower limb every 5 min for 3cycles
Primary Outcome Measure Information:
Title
Highest inotropic score
Time Frame
first 24 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18-60 years old
American Society of Anesthesiologists physical status II and III
Patients scheduled for open heart surgery
Exclusion Criteria:
Emergency surgery
Clinically significant kidney or liver disease
Patients allergic to local anesthetic
Patients with prolonged cardiopulmonary bypass time (>120 min)
Patients required intra-aortic balloon pump
Postoperative hemodynamic instability (including the occurrence of serious arrhythmia) or bleeding that required surgical re-exploration
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emad Zarief Kamel Said, M.D.
Organizational Affiliation
Department of Anesthesia, faculty of Medicine, Assiut University
Official's Role
Study Director
Facility Information:
Facility Name
Emad Zarief Kamel Said
City
Assiut
ZIP/Postal Code
71111
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Impact of Variable Types of Preconditioning Upon the Inotrope Score in Adult Patients, Undergoing Cardiac Surgery
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