Decision Relevance of Transient Circulatory Support for Acute Cardiogenic Shock: Patients' Characteristics and Follow-up
试验速览
- 阶段
- 不适用
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Hospital Mortality
研究概览
简要总结
The purpose of this multicenter prospective study is to determine if the decision of transient circulatory support (TCS) in cardiogenic shock is relevant. TCS is a recommended treatment of refractory cardiogenic shock but precise indications are not definitively founded. Some studies described patients with TCS in order to establish mortality predictive scores (ENCOURAGE, SAVE), but no study has assessed the clinical relevance of the TCS decision yet. Therefore, The investigators propose to compare the characteristics and the follow-up of patients in acute cardiogenic shock, once TCS implantation was decided or not by the heart team.
详细描述
This French multicenter prospective observational study is aimed at determining if the decision of transient circulatory support (TCS) in cardiogenic shock is pertinent, i.e. at least as effective as the medical treatment.
All patients with cardiogenic shock for whom indication of TCS was discussed within the multidisciplinary heart team (cardiologist, intensivist and cardiac surgeon) are consecutively included in the study.
Two groups of patients are defined:
- Patients with cardiogenic shock treated by medical treatement
- Patients with cardiogenic shock treated by TCS (extracorporeal circulatory life support and/or Impella).
The main objective is to compare mortality between the 2 groups. Secondary objectives are ICU follow-up characteristics and quality of life questionnaire at day 180.
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
- •Cardiogenic shock :
- •Systolic BP<90mmHg despite adequate filling pressure
- •Or need of cathecolamines to maintain SBP > 90mmHg
- •Signs of right-sided and/or left-sided congestion
- •Signs of tissue hypoperfusion : oliguria, cold sweated extremities, mental confusion, dizziness, narrow pulse pressure, blood lactate > 2 mmol/L
- •Short-term mechanical circulatory support discussed by the multidisciplinary heart team
排除标准
- •Post cardiotomy cardiogenic shock
- •Refractory cardiac arrest
- •Cardiac Arrest with No Flow >3 min and/or non shokable rythm
- •Contraindication to transient circulatory support because of comorbidities, neurological dysfunction, severe end-organ failure or aortic regurgitation
- •Pregnant or brest-feeding women,
- •Age < 18 year-old
结局指标
主要结局
Hospital Mortality
时间窗: From inclusion day to day 180
Mortality rate in the 2 groups at the time of hospital discharge
次要结局
- Short term mortality rate(From inclusion day to Intensive Care Unit (ICU) discharge or day 28 whichever came first)
- Bleeding events(From inclusion day to ICU discharge or day 28 whichever came first)
- ICU stays(From inclusion day to day 180)
- Respiratory failure(From inclusion day to ICU discharge or day 28 whichever came first)
- Hospital stays(From inclusion day to day 180)
- Long term mortality rate(From inclusion day to day 180)
- Acute renal failure(From inclusion day to ICU discharge or day 28 whichever came first)
- Thromboembolic events(From inclusion day to ICU discharge or day 28 whichever came first)
- Quality of life score SF 36(From inclusion day to day 180)