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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
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Ischemic Reperfusion Injury

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    June 21, 2021
    Last Updated
    July 2, 2021
    Sponsor
    Assiut University
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    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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