Randomized Trial of Fish Oil Infusion to Prevent Atrial Fibrillation After Cardiac Surgery
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Freedom of Atrial Fibrillation or other atrial arrhythmias
研究概览
简要总结
The purpose of this study is to evaluate efficacy of Polyunsaturated Fatty Acid for the prevention of Atrial Fibrillation and anti-inflammatory effects in patients after CABG surgery
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
- Double (Participant, Outcomes Assessor)
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
- •Elective CABG surgery.
- •Signed, documented informed consent prior to admission to the study.
排除标准
- •Unstable angina, requiring intervention or CABG <24 hrs after screening.
- •Decompensated congestive heart failure.
- •Chronic, persistent, paroxysmal atrial fibrillation.
- •Uncorrected significant valvular heart disease
- •Known hypersensitivity to the study drug
- •Left ventricular dysfunction (ejection fraction <35%)
- •Use of anti-arrhythmic drugs other than beta blockers
- •Non-cardiac illness with a life expectancy of less than 1 year
- •Bleeding diathesis or history of coagulopathy
- •Significant renal and liver insufficiency
- •Significant thyroid, pulmonary disease
- •Uncontrolled diabetes mellitus
- •Patients on anti-arrhythmic drugs
- •Patients with pacemaker
- •Patients unable to provide/sign informed consent.
- •Patients currently taking marine based omega-three fish oil supplements.
- •Disturbances in lipid metabolism, serum triglyceride value >3 mmol/l
研究组 & 干预措施
CABG and intralipid infusion
Procedure: CABG surgery and subcutaneous cardiac monitor implantation Drug: Intralipid Lipid emulsion (Intralipid) for intravenous use, 1 ml/kg/day daily for 7 days post-surgery period (The first infusion beginning in operative period)
干预措施: Intralipid (Drug)
CABG and omega-3 fatty acid infusion
Procedure: CABG surgery and subcutaneous cardiac monitor implantation Drug: Omegaven Lipid emulsion (omegaven) for intravenous use, 1 ml/kg/day daily for 7 days post-surgery period (The first infusion beginning in operative period)
干预措施: Omega-3 fish oil emulsion (Omegaven) (Drug)
结局指标
主要结局
Freedom of Atrial Fibrillation or other atrial arrhythmias
时间窗: 2 years
次要结局
- All cause mortality(3 years)
研究者
Efremov Sergey
Anesthesist
Meshalkin Research Institute of Pathology of Circulation