Lipid Emulsion in Cardiac Valve Replacement Surgery

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Ischemic Reperfusion Injury
• Intervention / Treatment: Drug: SMOFlipid; Other: Normal saline 0.9%

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 Type: Interventional
• Enrollment (Anticipated): 68
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: sara abdallah; Phone Number: 01009556520; Email: sara92abdallah@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
myocardium protection	assessment of lipid emulsion effect on post cardiopulmonary bypass ischemic reperfusion injury through measuring ( cardiac troponin (CTnI) in ng/ml )	72 hours
inflammatory response	assessment of the inflammatory response to lipid emulsion infusion through measuring ( Interleukein-6 (IL-6) in ng/l ).	72 hours
myocardium protection	assessment of lipid emulsion effect on post cardiopulmonary bypass ischemic reperfusion injury through (cardiac specific creatine kinase (CK-MB) in units/l )	72 hours
inflammatory response	assessment of the inflammatory response to lipid emulsion infusion through measuring ( C Reactive protein (CRP) in mg/l )	72 hours

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2021
• Primary Completion (Anticipated): August 1, 2023
• Study Completion (Anticipated): October 1, 2023

Study Registration Dates

• First Submitted: June 21, 2021
• First Submitted That Met QC Criteria: July 2, 2021
• First Posted (Actual): July 7, 2021

Study Record Updates

• Last Update Posted (Actual): July 7, 2021
• Last Update Submitted That Met QC Criteria: July 2, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Postoperative Complications; Reperfusion Injury; Pharmaceutical Solutions; Parenteral Nutrition Solutions; Fat Emulsions, Intravenous; SMOFlipid
• Other Study ID Numbers: lipid in cardiac surgery

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No