Effects of Lipid Emulsion on Myocardial Protection and Inflammatory Response in Cardiac Valve Replacement Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 68
- 主要终点
- myocardium protection
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients undergoing rheumatic valve replacement surgery
- •elective surgery
- •age between 18 and 80 years old
- •left ventricular ejection fraction > 0.4
排除标准
- •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)
研究组 & 干预措施
treatment
patients will receive intravenous infusion of SMOFlipid 20%
干预措施: SMOFlipid (Drug)
control
patients will receive intravenous infusion of normal saline 0.9%
干预措施: Normal saline 0.9% (Other)
结局指标
主要结局
myocardium protection
时间窗: 72 hours
assessment of lipid emulsion effect on post cardiopulmonary bypass ischemic reperfusion injury through (cardiac specific creatine kinase (CK-MB) in units/l )
inflammatory response
时间窗: 72 hours
assessment of the inflammatory response to lipid emulsion infusion through measuring ( C Reactive protein (CRP) in mg/l )
次要结局
未报告次要终点
研究者
sara abdallah
Assisstant lecturer of anesthesia and intensive care
Assiut University