Post Intensive Care Unit Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Rate of recurrence of atrial fibrillation
研究概览
简要总结
Atrial fibrillation (AF) is a common heart rhythm disorder in the intensive care unit (ICU). It can be precipitated by multiple factors but it is unclear whether AF persists after discharge from the ICU, and long term. This study will investigate whether AF recurs up to one year after ICU discharge.
详细描述
Atrial fibrillation (AF) is the most common heart rhythm disorder encountered in the intensive care unit (ICU). It can be precipitated by multiple factors present in critically ill patients, such as tissue hypoxia, metabolic disorders etc. There is a paucity of data regarding the persistence of AF in these patients after discharge from the ICU, and in the longer term. Therefore, this study will investigate whether AF recurs up to one year after ICU discharge using an implantable ECG Holter device in adult patients discharged alive from the ICU, with documented new onset AF.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Age >18 years
- •New onset atrial fibrillation diagnosed in the ICU (12 lead ECG or documented episode of atrial fibrillation lasting at least 30 seconds)
- •Patient hospitalized in the ICU with at least one of the following two criteria:
- •orotracheal intubation for mechanical ventilation
- •AND/OR treatment with amines (vasopressors or inotropic agents)
- •Written informed consent
- •Patient affiliated to a social security regime (or beneficiary thereof)
排除标准
- •Documented history of atrial fibrillation
- •patients admitted to the ICU after cardiothoracic surgery
- •Patients with life expectancy <12 months
- •Patients under legal or judicial protection
- •Patients with no social security coverage
- •Patients within the exclusion period of another clinical trial
结局指标
主要结局
Rate of recurrence of atrial fibrillation
时间窗: up to 1 year after ICU discharge
Any episode of atrial fibrillation, atrial tachycardia or atrial flutter lasting at least 1 minute, as documented on the implantable device recordings
次要结局
- Burden of atrial fibrillation in absolute value(up to 2 years after ICU discharge)
- Rate of Stroke(up to 2 years after ICU discharge)
- Number of participants with Change in treatment(up to 2 years after ICU discharge)
- Burden of atrial fibrillation (percentage of time spent in atrial fibrillation)(up to 2 years after ICU discharge)