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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04951791
Other study ID # lipid in cardiac surgery
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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