The Usefulness of Myocardial Work IndeX in ExtraCorporeal Membrane Oxygenation Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Cardiovascular mortality, need for long-term mechanical circulatory support or heart transplantation
研究概览
简要总结
Investigation of the potential prognostic role of non-invasive myocardial work in patients receiving veno-arterial extracorporeal membrane oxygenation therapy.
详细描述
The study aims to examine the prognostic role of non-invasive myocardial work in veno-arterial extracorporeal membrane oxygenation therapy patients. Subjects with cardiogenic shock regardless of etiology will be enrolled 48-72 hours after the initiation of mechanical circulatory support. It is hypothesized that non-invasive myocardial work may be an independent prognosticator of the outcome.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older age
- •Severe cardiogenic shock requiring the initiation of VA-ECMO therapy
- •Stabile hemodynamic state and oxigenation with VA-ECMO and vasoactive support
- •Informed written consent (due to the nature of the study, from a legally eligible relative of the patient)
排除标准
- •Younger than 18 years of age
- •Unstable hemodynamic state or suboptimal oxigenation despite established VA-ECMO and vasoactive support
- •Severe neurological damage or confirmed brain death at the time of enrollment which squarely indicates therapy limitation and poor short-term outcome
- •Transesophageal echocardiography is contraindicated
- •Suboptimal echocardiographic window
结局指标
主要结局
Cardiovascular mortality, need for long-term mechanical circulatory support or heart transplantation
时间窗: 30 days
The total number of patients who die from cardiovascular cause, or require for transition to long-term mechanical circulatory support (LVAD/BiVAD), or heart transplantation
次要结局
- Successful weaning from mechanical ventilation(30 days)
- Discharge from hospital(30 days)
- Need for renal replacement therapy(30 days)
- Ventilator-free days(30 days)
- All-cause mortality(30 days)
- Discharge from intensive care unit(30 days)
- VA-ECMO-free days(30 days)
研究者
Balint Karoly Lakatos
Assistant Professor
Semmelweis University Heart and Vascular Center