Lipid Emulsion in Cardiac Valve Replacement Surgery

Not Applicable

• Conditions: Ischemic Reperfusion Injury
• Interventions: Other: Normal saline 0.9%; Drug: SMOFlipid

• Registration Number: NCT04951791
• Lead Sponsor: Assiut University

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.

Study Timeline

• Study First Submitted: 2021-06-21
• Status Verified: 2021-07
• Study First Submitted QC: 2021-07-02
• Last Update Submitted: 2021-07-02
• Study First Posted: 2021-07-07
• Last Update Posted: 2021-07-07
• Study Start: 2021-08
• Primary Completion: 2023-08
• Study Completion: 2023-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 68

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control	Normal saline 0.9%	patients will receive intravenous infusion of normal saline 0.9%
treatment	SMOFlipid	patients will receive intravenous infusion of SMOFlipid 20%

Primary Outcome Measures

Name	Time	Method
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 )
inflammatory response	72 hours	assessment of the inflammatory response to lipid emulsion infusion through measuring ( C Reactive protein (CRP) in mg/l )