Early Versus Late Initiation of ECMO Trial (ELIEO-Trial)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 508
- 试验地点
- 2
- 主要终点
- 90 day all cause mortality
研究概览
简要总结
This trial is a prospective randomized multicenter trial that assigns patients to either a treatment for Acute Respiratory Distress Syndrome (ARDS) with an Extracorporal Membrane Oxygenation (ECMO) immediately after admission to the intensive care unit or conservative treatment. The later can undergo ECMO following failure of conservative therapy as a rescue therapy. Patients will be included within 24 hours of the onset of symptoms of ARDS and will be randomized according to standard procedure. Follow-up will be performed until day 90 after study inclusion.
详细描述
Patients suffering acute ARDS defined according to the Berlin Definition starting from severe stage with acute onset and (i) ratio partial arterial pressure of oxygen fraction of inspired oxygen inspired oxygen fraction (PaO2/ FiO2) ≤ 200 (ii) Bilateral opacities consistent with pulmonary edema on frontal chest radiograph, and (iii) requirement for positive pressure ventilation via an endotracheal tube or non-invasive ventilation (iv) no clinical evidence of left atrial hypertension, or if measured, a Pulmonary Arterial Wedge Pressure (PAOP) less than or equal to 18 mm Hg (v) less than 96 hours from onset of ARDS (vi) less than 7 days from the initiation of mechanical ventilation will be treated by ECMO either within 24 hours to referral to an ARDS ECMO center or as rescue therapy after failure of conventional therapy.
Outcome measures have been chosen according to robustness and sensitivity to change. They are of high clinical impact and reflect the treatment effect desired by clinicians.
Primary efficacy endpoint: All cause mortality by 90-days.
Key secondary endpoints are:
- 28 day all cause mortality 3. SOFA Organ Failure Scores at day at day 1-7, 14, 28 and 90 days 4. Duration of mechanical ventilation support 5. ICU length of stay
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
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
- •ARDS as defined according to the Berlin Definition1
- •The term "acute onset" is defined as follow: the duration of the hypoxemia criterion and the chest radiograph criterion must be ≤ 7 days at the time of randomization.
- •Patients must be enrolled within 96 hours of onset of ARDS and no later than 7 days from the initiation of mechanical ventilation.
排除标准
- •Age less than 18 years
- •More than 7 days since initiation of mechanical ventilation
- •more than 96 hours since meeting inclusion criteria
- •patient, surrogate or physician not committed to full intensive care support
- •pregnancy
结局指标
主要结局
90 day all cause mortality
时间窗: 90 days after study inclusion
90 day all cause mortality
次要结局
- Sepsis-related organ failure assessment score (SOFA) Organ Failure Scores(1-14, 28 and 90 days after study inclusion)
- Duration of mechanical ventilation(within 90 days after study inclusion)
- 28 day all cause mortality(28 days after study inclusion)
- ICU length of stay(overall length of stay)