Reduction of Atrial Fibrillation Study in Patients Undergoing Coronary Artery Bypass Grafting. (RASCABG 1 Study)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- - Time to symptomatic atrial fibrillation, cerebral apoplexy/ transitory cerebral infarction (TCI), acute myocardial infarction (AMI), or death.
研究概览
简要总结
The purpose of this study is to determine whether postoperatively oral treatment with high dosis amiodarone for five days after intravenously admitted bolusinfusion will minimize the risk for development of atrial fibrillation after coronary artery bypass grafting.
详细描述
New-onset atrial fibrillation (AF) after coronary bypass grafting (CABG) is common, with an incidence ranging from 5%-65%.
Although postoperative atrial tachyarrhythmia is often regarded as a temporary problem related to the operation and therefore innocuous, this complication has clinically significant adverse effects on patient outcome.
The purpose of this study was to find a good treatment without severe adverse effects to minimize the incidence of AF and maybe reduced the hemodynamic stress which AF is well known to cause. This would indicate that the risk of developing fatal events like cerebral apoplexy, TCI, AMI and death will be minimized as a result of the improved hemodynamic.
Overall AF is associated with risk of illness and for the development of severe complications as cerebral apoplexy, TCI, AMI and death with a factor 2-3.
There has furthermore been seen a twofold increase in the duration of intensive care unit stay and prolongation of the total hospitalization time with attendant increased hospitalization cost.
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
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •enlistment for an elective CABG
- •age more than 18 years
- •willingness to be randomised
- •provision of informed consent
排除标准
- •enlistment for other types of heart surgery
- •earlier heart surgery
- •resting heart rate below 40 bpm.
- •AV-blockage of any degree
- •preoperative atrial fibrillation or flutter
- •former known atrial fibrillation or flutter lasting more than one month
- •hepatic dysfunction (ALAT > twice the upper normal limit)
- •hyperthyroidism
- •pregnancy
- •breastfeeding
- •known adverse reactions to amiodarone
结局指标
主要结局
- Time to symptomatic atrial fibrillation, cerebral apoplexy/ transitory cerebral infarction (TCI), acute myocardial infarction (AMI), or death.
- Time to symptomatic or asymptomatic atrial fibrillation, cerebral apoplexy/TCI, AMI or death;
- Time to symptomatic or asymptomatic atrial fibrillation
- Time to symptomatic atrial fibrillation
All measured at postoperative day 7 and 30.
次要结局
- - Length of stay at Skejby Sygehus.
- - Length of stay at Skejby Sygehus and local hospital.
- - Length of stay at the intensive care unit (ICU) and intermediary unit, Skejby Sygehus