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Clinical Trials/NCT04951791
NCT04951791
Unknown
Not Applicable

Effects of Lipid Emulsion on Myocardial Protection and Inflammatory Response in Cardiac Valve Replacement Surgery

Assiut University0 sites68 target enrollmentAugust 2021

Overview

Phase
Not Applicable
Intervention
SMOFlipid
Conditions
Ischemic Reperfusion Injury
Sponsor
Assiut University
Enrollment
68
Primary Endpoint
myocardium protection
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2021
End Date
October 2023
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

sara abdallah

Assisstant lecturer of anesthesia and intensive care

Assiut University

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)

Arms & Interventions

treatment

patients will receive intravenous infusion of SMOFlipid 20%

Intervention: SMOFlipid

control

patients will receive intravenous infusion of normal saline 0.9%

Intervention: Normal saline 0.9%

Outcomes

Primary Outcomes

myocardium protection

Time Frame: 72 hours

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

inflammatory response

Time Frame: 72 hours

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

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