Fish Oil to Inhibit Supraventricular Arrhythmias After Cardiac Surgery: The Fish Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- Number of Participants Who Developed Postoperative Atrial Fibrillation
研究概览
简要总结
The primary objective of this study is to determine if omega-3 polyunsaturated fatty acids reduce atrial fibrillation and other outcomes after cardiac surgery. In this placebo-controlled trial, patients undergoing elective coronary artery bypass graft surgery with or without valve repair will be treated with omega-3 polyunsaturated fatty acids perioperatively. The following hypotheses will be tested: 1. omega-3 polyunsaturated fatty acids reduces the incidence of atrial fibrillation (AF) after cardiac surgery, 2. omega-3 polyunsaturated fatty acids, administered in the perioperative period for cardiac surgery, decreases postoperative complication rates, and 3. omega-3 polyunsaturated fatty acids decrease intensive care unit and hospital length-of-stay.
详细描述
Atrial fibrillation is the most common complication after bypass surgery. It is a significant burden to the healthcare system because it is associated with increased hospital costs and a longer hospital length-of-stay. Atrial fibrillation occurring after bypass surgery is associated with increased morbidity and mortality. Atrial fibrillation is also associated with an increased risk for strokes, use of potentially harmful drugs, and the need for pacemaker therapy.
This study is for patients who are undergoing elective bypass surgery. Patients who meet study criteria and who consent to participate in the study will be randomized to treatment with omega-3 fatty acids or matching corn oil placebo, prior to surgery. After surgery, treatment will continue until the primary endpoint, atrial fibrillation, is reached, or 14 days, whichever is first.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-85 years old.
- •Elective coronary artery bypass (CABG) operation with or without concomitant valve surgery planned for at least 2 days after enrollment.
- •Signed, documented informed consent prior to admission to the study.
排除标准
- •Urgent or emergent bypass required to be performed <24 hrs after screening.
- •Unstable angina, requiring intervention or CABG <24 hrs after screening.
- •Decompensated congestive heart failure.
- •Chronic, persistent atrial fibrillation - patient in atrial fibrillation at the time of screening or enrollment or scheduled for a maze procedure or pulmonary vein isolation at the time of surgery.
- •Known sensitivity to Omacor (0mega-3 acid ethyl esters) and hypersensitivity to fish, fish products or corn oil.
- •Patients requiring warfarin or Lovenox the 2 days prior to bypass surgery.
- •Patients on Class I or III antiarrhythmic agents (quinidine, procainamide, disopyramide, flecainide, propafenone, moricizine, dofetilide, sotalol, amiodarone) or who have taken these drugs within 5 elimination half-lives of the drug (or within 2 months for amiodarone).
- •Patients who are pregnant or nursing.
- •Patients unable to provide/sign informed consent.
- •Patients currently enrolled in another clinical trial without a 30 day washout period.
- •Patients currently taking marine based omega-three fish oil supplements.
研究组 & 干预措施
fish oil , corn oil
Highly purified pharmaceutical grade omega three polyunsaturated fatty acids
干预措施: Omega Three Polyunsaturated fatty acids (Drug)
placebo
olive oil
干预措施: Omega Three Polyunsaturated fatty acids (Drug)
结局指标
主要结局
Number of Participants Who Developed Postoperative Atrial Fibrillation
时间窗: 14 days
The primary outcome in this study is post-bypass atrial fibrillation documented by ECG or rhythm strip and requiring treatment.
次要结局
未报告次要终点
研究者
Chirag Sandesara
MD
University of Iowa