Lipid Emulsion in Cardiac Valve Replacement Surgery

Ischemic Reperfusion Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04951791
• Other study ID #: lipid in cardiac surgery
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2021
• Est. completion date: October 2023

Study information

• Verified date: July 2021
• Source: Assiut University
• Contact: sara abdallah
• Phone: 01009556520
• Email: sara92abdallah[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 68
• Est. completion date: October 2023
• Est. primary completion date: August 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Ischemic Reperfusion Injury
• Reperfusion Injury

Intervention

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:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	myocardium protection	assessment of lipid emulsion effect on post cardiopulmonary bypass ischemic reperfusion injury through measuring ( cardiac troponin (CTnI) in ng/ml )	72 hours
Primary	inflammatory response	assessment of the inflammatory response to lipid emulsion infusion through measuring ( Interleukein-6 (IL-6) in ng/l ).	72 hours
Primary	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
Primary	inflammatory response	assessment of the inflammatory response to lipid emulsion infusion through measuring ( C Reactive protein (CRP) in mg/l )	72 hours