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Lipid Emulsion in Cardiac Valve Replacement Surgery

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04951791
Collaborator
(none)
68
Enrollment
2
Arms
26
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
68 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
randomized controlled trialrandomized controlled trial
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Effects of Lipid Emulsion on Myocardial Protection and Inflammatory Response in Cardiac Valve Replacement Surgery
Anticipated Study Start Date :
Aug 1, 2021
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Oct 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: treatment

patients will receive intravenous infusion of SMOFlipid 20%

Drug: SMOFlipid
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
Other Names:
  • smoflipid 20% lipid emulsion

    		•
    Placebo Comparator: control

    patients will receive intravenous infusion of normal saline 0.9%

    Other: Normal saline 0.9%
    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.

    Outcome Measures

    Primary Outcome Measures

    1. myocardium protection [72 hours]

      assessment of lipid emulsion effect on post cardiopulmonary bypass ischemic reperfusion injury through measuring ( cardiac troponin (CTnI) in ng/ml )

    2. inflammatory response [72 hours]

      assessment of the inflammatory response to lipid emulsion infusion through measuring ( Interleukein-6 (IL-6) in ng/l ).

    3. myocardium protection [72 hours]

      assessment of lipid emulsion effect on post cardiopulmonary bypass ischemic reperfusion injury through (cardiac specific creatine kinase (CK-MB) in units/l )

    4. inflammatory response [72 hours]

      assessment of the inflammatory response to lipid emulsion infusion through measuring ( C Reactive protein (CRP) in mg/l )

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Assiut University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    sara abdallah, Assisstant lecturer of anesthesia and intensive care, Assiut University
    ClinicalTrials.gov Identifier:
    NCT04951791
    Other Study ID Numbers:
    • lipid in cardiac surgery
    First Posted:
    Jul 7, 2021
    Last Update Posted:
    Jul 7, 2021
    Last Verified:
    Jul 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Reperfusion Injury
    SMOFlipid

    Study Results

    No Results Posted as of Jul 7, 2021