Lipid Emulsion in Cardiac Valve Replacement Surgery

NCT04951791 | Unknown

• 1 other identifier: lipid in cardiac surgery
• Study Type: interventional
• Target: 68
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Ischemic Reperfusion Injury

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

treatment

EXPERIMENTAL

patients will receive intravenous infusion of SMOFlipid 20%

Drug: SMOFlipid

control

PLACEBO COMPARATOR

patients will receive intravenous infusion of normal saline 0.9%

Other: Normal saline 0.9%

Interventions

SMOFlipid DRUG

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

Also known as: smoflipid 20% lipid emulsion

treatment

Normal saline 0.9% OTHER

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.

control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients undergoing rheumatic valve replacement surgery
• elective surgery
• age between 18 and 80 years old
• left ventricular ejection fraction \> 0.4

You may not qualify if:

• 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)

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Interventions

SMOFlipid; Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

sara abdallah

CONTACT

01009556520; sara92abdallah@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisstant lecturer of anesthesia and intensive care

Model Details: randomized controlled trial

Study Record Dates

• First Submitted: June 21, 2021
• First Posted: July 7, 2021
• Study Start: August 1, 2021
• Primary Completion: August 1, 2023
• Study Completion: October 1, 2023
• Last Updated: July 7, 2021

Record last verified: 2021-07