Lipid Emulsion in Cardiac Valve Replacement Surgery
Primary Purpose
Ischemic Reperfusion Injury
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SMOFlipid
Normal saline 0.9%
Sponsored by

About this trial
This is an interventional prevention trial for Ischemic Reperfusion Injury
Eligibility Criteria
Inclusion Criteria:
- patients undergoing rheumatic valve replacement surgery
- elective surgery
- age between 18 and 80 years old
- left ventricular ejection fraction > 0.4
Exclusion Criteria:
- Emergency and Re do surgery,
- Positive base line CTnI or CK-MB,
- Preoperative treatment with intralipid in the last 1 month.
- History of allergy to (peanut, eggs, and soya bean)
- Implanted pacemaker,
- previous myocardial infarction,
- Diabetic or other metabolic disorders,
- Significant Renal impairment (Cr > 1.5) or on hemodialysis
- Significant hepatic dysfunction (INR>2)
- Drugs interfere as (cyclosporine)
- Infection (WBC >12)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
treatment
control
Arm Description
patients will receive intravenous infusion of SMOFlipid 20%
patients will receive intravenous infusion of normal saline 0.9%
Outcomes
Primary Outcome Measures
myocardium protection
assessment of lipid emulsion effect on post cardiopulmonary bypass ischemic reperfusion injury through measuring ( cardiac troponin (CTnI) in ng/ml )
inflammatory response
assessment of the inflammatory response to lipid emulsion infusion through measuring ( Interleukein-6 (IL-6) in ng/l ).
myocardium protection
assessment of lipid emulsion effect on post cardiopulmonary bypass ischemic reperfusion injury through (cardiac specific creatine kinase (CK-MB) in units/l )
inflammatory response
assessment of the inflammatory response to lipid emulsion infusion through measuring ( C Reactive protein (CRP) in mg/l )
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04951791
Brief Title
Lipid Emulsion in Cardiac Valve Replacement Surgery
Official Title
Effects of Lipid Emulsion on Myocardial Protection and Inflammatory Response in Cardiac Valve Replacement Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 2021 (Anticipated)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Myocardial protection has become an essential adjunctive measure in cardiac surgery to bail the myocardium out of ischemia/reperfusion-induced damage during the operation.
Experimental studies have shown that lipid emulsion infusion just before reperfusion (i.e., intralipid postconditioning (ILPC)) could reduce myocardial infarct sizes, improve cardiac function, and reduce myocardial I/R injuries, despite the interesting experimental findings, the potential clinical usage of lipid emulsion in preventing myocardial I/R injury needs to be further investigated.
Detailed Description
The study of myocardial protection has improved aiming to prevent intraoperative myocardial injury, which can lead to ventricular dysfunction, arrhythmias, low cardiac output and other complications, often irreversible ones.
Nowadays there are numerous methods of myocardial protection during cardiac surgery, But still there is no best myocardial protection technique.
Despite improved myocardial protection strategies, cardioplegic arrest and ischemia still result in ischemic reperfusion injury during cardiac surgery.
Many drugs have proved a pharmacological postconditioning effect on the heart at the onset of reflow and had been shown to limit infarction size and decrease the ischemic/reperfusion injury ,Postconditioning (POC) has been reported to promote left ventricular functional recovery after global ischemia with cardioplegic arrest on cardiopulmonary bypass in a large animal model Smoflipid is a sterile safe lipid emulsion comprised of soybean oil (30%), medium chain triglycerides (30%) olive oil (25%) & fish oil (15%) that has been associated with decreased oxidative injury, improved liver function and increased antioxidant activity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Reperfusion Injury
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
68 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
treatment
Arm Type
Experimental
Arm Description
patients will receive intravenous infusion of SMOFlipid 20%
Arm Title
control
Arm Type
Placebo Comparator
Arm Description
patients will receive intravenous infusion of normal saline 0.9%
Intervention Type
Drug
Intervention Name(s)
SMOFlipid
Other Intervention Name(s)
smoflipid 20% lipid emulsion
Intervention Description
will receive intravenous infusion of 2ml\kg of smoflipid 20%, in the internal jugular vein 10 minutes before removal of aortic cross clamp in a constant speed
Intervention Type
Other
Intervention Name(s)
Normal saline 0.9%
Intervention Description
will receive intravenous infusion of 2ml\kg of normal saline 0.9%, in the internal jugular vein 10 minutes before removal of aortic cross clamp in a constant speed.
Primary Outcome Measure Information:
Title
myocardium protection
Description
assessment of lipid emulsion effect on post cardiopulmonary bypass ischemic reperfusion injury through measuring ( cardiac troponin (CTnI) in ng/ml )
Time Frame
72 hours
Title
inflammatory response
Description
assessment of the inflammatory response to lipid emulsion infusion through measuring ( Interleukein-6 (IL-6) in ng/l ).
Time Frame
72 hours
Title
myocardium protection
Description
assessment of lipid emulsion effect on post cardiopulmonary bypass ischemic reperfusion injury through (cardiac specific creatine kinase (CK-MB) in units/l )
Time Frame
72 hours
Title
inflammatory response
Description
assessment of the inflammatory response to lipid emulsion infusion through measuring ( C Reactive protein (CRP) in mg/l )
Time Frame
72 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients undergoing rheumatic valve replacement surgery
elective surgery
age between 18 and 80 years old
left ventricular ejection fraction > 0.4
Exclusion Criteria:
Emergency and Re do surgery,
Positive base line CTnI or CK-MB,
Preoperative treatment with intralipid in the last 1 month.
History of allergy to (peanut, eggs, and soya bean)
Implanted pacemaker,
previous myocardial infarction,
Diabetic or other metabolic disorders,
Significant Renal impairment (Cr > 1.5) or on hemodialysis
Significant hepatic dysfunction (INR>2)
Drugs interfere as (cyclosporine)
Infection (WBC >12)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
sara abdallah
Phone
01009556520
Email
sara92abdallah@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Lipid Emulsion in Cardiac Valve Replacement Surgery
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