Effects of Intravenous n-3 Polyunsaturated Fatty Acid Administration in Critically Ill Cardiac Surgery and Myocardial Infarction Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Incorporation of n-3 PUFA into platelet cell membrane and myocardial tissue
研究概览
简要总结
A large body of evidence has accumulated showing that n-3 PUFAs exert extensive cardiac effects. The development of commercial solutions of FO opens perspectives for therapeutic applications in patients with acute cardiac conditions.the 3 following hypotheses will be addressed in patients requiring cardiac surgery under cardiopulmonary bypass or after myocardial infarction:perioperative /post-PTCA intravenous fish oil modifies the composition of membrane phospholipids in platelets and cardiac cells, blunts the physiological response to cardiac surgery/myocardial infarction, and reduces the incidence of arrhythmias, and reduces the occurrence of systolic dysfunction.
详细描述
A. Randomized trial in 40 cardiac surgery patients Early rapid infusion of fish oil (3 times in 24 hours) in cardiac surgery patients.
B. Randomized trial 20 myocardial infarction patients (abandonned) Continuous infusion of the same dose over 24hrs in the myocardial infarction patients
Additional trial in healthy volunteers (investigating physiological changes after cardiac study):
-Open trial in 8 healthy lean volunteers to investigate the impact of the same 0.6 g/kg FO dose IV (Week 1: 3hrs), and then orally on week 2, on platelet n-3 PUFA incorporation, platelet function, heart rate and peak flow response to stress test.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Coronary artery disease requiring elective surgical repair under cardiopulmonary bypass
- •Acute myocardial infarction requiring ICU management
排除标准
- •Absence of consent
- •Ventricular ejection fraction < 35%
- •Beating heart surgery or emergency surgery
- •Hypercholesterolemia > 5 mmol/l
- •Thrombolysis
- •Chronic steroid therapy
- •Acute or chronic renal failure prior to surgery (plasma creatinine > 150 umol/l)
- •Chronic coagulation disorder
- •Premenopausal female
- •Consumption of more than 3 times fish per week
研究组 & 干预措施
Placebo
Saline (No lipid emulsion)
干预措施: Saline (Drug)
Fish oil emulsion
3 infusions of 0.2 g/kg omega-3 PUFA within 24 hours in cardiac surgery (continuous infusion post-PTCA)
干预措施: Fish oil emulsion (Drug)
结局指标
主要结局
Incorporation of n-3 PUFA into platelet cell membrane and myocardial tissue
时间窗: 48 hours
The primary outcome is the determination of magnitude of the incorporation and the time required for incorporation of omega-3 fatty acid cell membrane composition after short intravenous infusions was unknown until the present study (HPLC determination of fatty acid membrane composition in all patients)
次要结局
- Inflammatory and metabolic response(From operation to ICU discharge (maximum 28 days))
- Global clinical outcome(From operation to hospital discharge (maximum 28 days))
- Myocardial recovery after surgery(From operation to hospital discharge (maximum 28 days))
研究者
Mette M Berger
Prof
Centre Hospitalier Universitaire Vaudois