Randomised Control Study on Cardiac Protection With Intralipid® in Patients Undergoing Coronary Artery Bypass Grafting on Cardiopulmonary Bypass
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Comparison of the serum Troponin I Leak over 72 hours
研究概览
简要总结
This study will evaluate the benefit of Intralipid® or placebo administered prior to reperfusion to limit ischemia reperfusion injury as measured by the geometric mean difference of the release of troponin I over 72 hours after coronary artery bypass.
详细描述
A single center randomised control study on cardiac protection with INTRALIPD in patients undergoing coronary artery bypass grafting on cardiopulmonary bypass.
Purpose and objectives:
Reperfusion after coronary artery bypass grafting is associated with a modifiable leak in cardiac Troponin I (cTnI) secondary to ischemia reperfusion injury. The purpose of the study is to test whether INTRALIPID administered at reperfusion can limit myocardial reperfusion injury as measured by cTnI release in patients undergoing coronary artery bypass grafting.
Trial design:
This study is a prospective single centre double blind placebo controlled randomised trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First time elective isolated CABG
- •Ejection Fraction greater the 40 by echocardiography or subjectively judged as preserved or good by ventriculography.
- •Male and female adults between 18 and 65 years of age.
- •Women must have a negative serum pregnancy test at screening.
- •Body mass Index (BMI) between 21 and 35 kg/m
- •Baseline clinical laboratory tests at screening within the reference ranges
排除标准
- •Received an investigational drug or participated in another research trial within 30 days before the first dose of trial drug or at any time throughout the trial.
- •Evidence of current or history of clinically significant oncologic, pulmonary, hepatic with elevated liver functions enzymes 1.5* Upper Limit of Normal (ULN), cardiovascular, haematologic, metabolic, neurological, immunologic, nephrologic, endocrine particularly Diabetes Mellitus as defined by the American Diabetic Association, psychiatric disease, or clinically significant current infection.
- •Patients with renal impairment with a creatinine greater than 200 μmol/L
- •Evidence of current or history of clinically significant gastrointestinal (excluding appendectomy, cholecystectomy) disease.
- •Myocardial infarction within the previous 2 weeks.
- •Patients who require inotropic or mechanical cardiac support prior to anaesthesia.
- •Contraindication to the trial drugs Previous Hypertriglyceridemia pancreatitis. Hypertriglyceridemia with plasma triglyceride levels > 5.7mmol/L Egg, peanut and soybean allergy.
研究组 & 干预措施
Intralipid 20%
Intravenous single bolus of 1.5 ml/kg of Intralipid 20% over 3 minutes.
干预措施: Intralipid 20% (Drug)
Modified Ringers Lactate
Intravenous single bolus of 1.5 ml/kg of MRL over 3 minutes.
干预措施: Modified Ringers Lactate (Drug)
结局指标
主要结局
Comparison of the serum Troponin I Leak over 72 hours
时间窗: Over 72 hours
The primary endpoint will be assessed by the geometric mean (95% CI) difference between the protocol and control groups of the area under the curve for the cTnI concentration in serum over 72 hours (sampled at 1, 6, 12, 24, 48 and 72 hours) calculated according to the trapezoid rule.
次要结局
- Signaling Pathways of intralipid induced cardiac protection(5 minutes after reperfusion)
研究者
Nkanyiso Hadebe
Dr
University of Cape Town