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Lipid Emulsion in Cardiac Valve Replacement Surgery

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04951791
Enrollment
68
Registered
2021-07-07
Start date
2021-08-31
Completion date
2023-10-31
Last updated
2021-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Reperfusion Injury

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.

Interventions

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

OTHERNormal 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.

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

randomized controlled trial

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
myocardium protection72 hoursassessment of lipid emulsion effect on post cardiopulmonary bypass ischemic reperfusion injury through measuring ( cardiac troponin (CTnI) in ng/ml )
inflammatory response72 hoursassessment of the inflammatory response to lipid emulsion infusion through measuring ( Interleukein-6 (IL-6) in ng/l ).

Contacts

Primary Contactsara abdallah
sara92abdallah@gmail.com01009556520

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026