NCT04951791

Lipid Emulsion in Cardiac Valve Replacement Surgery

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 68 (estimated)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ischemic Reperfusion Injury

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-08-01
• Primary completion: 2023-08-01
• Completion: 2023-10-01
• First posted: 2021-07-07
• Last updated: 2021-07-07