Incidence and Morbidity of Cardiac Rhythm Disorders in Patients Assisted by Extra Corporeal Membrane Oxygenation Veno-arterial (ECMO VA) for Refractory Cardiogenic Shock
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 35
- 主要终点
- Number of atrial fibrillation in patients assisted by veno-arterial ECMO.
研究概览
简要总结
Brief Summary : Rhythm disorders are a frequent and potentially serious complication of critical patients in the ICU and postoperative cardiac surgery. In particular, atrial fibrillation (AF) is the most common rhythm disorder in patients admitted to the ICU and is associated with excess mortality during acute circulatory failure. In postoperative cardiac surgery, AF affects 15 to 45% of patients. In addition to hemodynamic effects, AF increases the risk of stroke, bleeding, respiratory or renal failure, and doubles mortality at 30 days and 6 months. In the longer term, the recurrence rate of AF within 1 year after hospital discharge is about 50%. Similarly, other rhythm disorders, supraventricular or ventricular, can be life-threatening in ICU patients.
While the incidence and complications of rhythm disorders are well documented during sepsis, cardiogenic shock or after cardiac surgery, there are to our knowledge no data on the frequency and complications of rhythm disorders in patients assisted by VA ECMO.
The primary objective is to describe the incidence of supraventricular rhythm disorders in patients assisted by VA ECMO.
详细描述
This study is an observational study to describe the conditions of occurrence of arrhythmias, particularly atrial fibrillation, in patients supported by VA ECMO, as well as their short-term and long-term prognosis. Patients will be recruited from the intensive care units and CRFs will be completed by the investigators at each of the participating centers. Data will be collected directly from the medical records, except for vital status at 1 year, which may be collected by telephone from the patient by the investigator at the center in the absence of data in the medical record.
Atrial fibrillation episodes will be recorded on a 12-lead electrocardiogram and securely transmitted to the coordinating center. In addition, investigators will send weekly data to the principal investigator for incidence calculation. Patients or their relatives will be informed about the study by an information sheet presented and explained by the investigator or another person authorized to conduct the research. The investigator will record the patient's consent in the patient's medical record.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patient 18 years of age or older
- •Assistance with VA ECMO
排除标准
- •Opposition to the use of data.
- •Persons under legal protection (curators, guardianship), judicially safeguarded.
- •VA ECMO for refractory cardiac arrest.
研究组 & 干预措施
Patients with refractory cardiogenic shock assisted with ECMO VA
干预措施: Follow up by phone call (Other)
结局指标
主要结局
Number of atrial fibrillation in patients assisted by veno-arterial ECMO.
时间窗: day 30
Atrial fibrillation will be defined as an episode of AF ≥ 30 minutes or requiring pharmacological or electrical cardioversion.
次要结局
- duration of ICU stay(day 30)
- Number of ventricular rhythm disorders(day 30)
- duration of VA ECMO support(day 30)
- duration of mechanical ventilation(day 30)
- Number of living patient(day 28, day 360)
- Number of thrombo-embolic complications(day 30)
- Number of neurological complications(day 30)
- Number of bleeding complications(day 30)