EXODUS: Extracorporeal Lung Assist Device in Acute Lung Impairment: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 13
- 主要终点
- Incidence of an increase in SOFA-Score ≥3 points or death within 28 days
研究概览
简要总结
The purpose of this study is to compare the effect of interventional Lung Assist iLA activve to standard therapy in mechanically ventilated patients with severe acute lung impairment. Hypothesis: iLA(active) reduces the incidence of an increase in SOFA-Score of ≥3 points (or death) within 28 days compared to standard treatment.
详细描述
Background:
Mechanical ventilation in patients with acute lung impairment further injures the lungs by inspiration forces and inflammatory response. Large efforts have been invested in reducing ventilator-associated lung damage by lower tidal volumes. However, benefits are limited by potential harms of permissive hypercapnia.
Therefore, extracorporeal membrane oxygenation (ECMO) and CO2-removal have been studied for more than 40 years. However, ECMO remained restricted to few specialized centres capable to provide extensive resources. Transfer of patients implicates loss of time and risks of transportation. Therefore, less invasive devices have been developed, including "pump-less "extracorporeal lung assist" (pECLA) and pump-driven ECLA (e.g. iLA activve). Despite pilot trials supporting feasibility, safety and efficient oxygenation and decarboxylation by pump-driven ECLA, there are no randomized controlled trials (RCT) proving a benefit regarding long-term endpoints.
Objectives:
Therefore, the aim of this multicentre RCT is to compare the outcome of 150 patients with early (after ≤96h of mechanical ventilation) acute lung impairment treated by pump-driven ECLA with iLA activve with a blood flow of at least 1L/min vs. 150 controls with standard intensive care including low tidal volume ventilation.
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 (Outcomes Assessor)
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
- •Potentially reversible lung failure AND
- •Cumulative Murray score ≥6 points without radiological points for a maximum of 48h AND
- •Cumulative Murray score ≥4 points for pO2/FiO and PEEP AND
- •Cumulative Murray score ≥1 point for pO2/FiO
- •Mechanical ventilation for ≤96h AND
- •Age ≥ 18 years.
排除标准
- •SOFA-Score >20
- •Life expectancy <24h
- •mechanical ventilation >96h
- •Heparin-induced thrombopenia
- •Intracranial bleeding
结局指标
主要结局
Incidence of an increase in SOFA-Score ≥3 points or death within 28 days
时间窗: 28 days
次要结局
- Meta-analysis(6 months)
- Resource use and economic outcomes(6 months)
- Single organ failures as assessed by SOFA(28 days, ICU stay)
- Association of the fluid balance to the secondary endpoint "death or severe disability after 6 months defined as confinement to bed and inability to wash or dress alone)"(6 months)
- Prediction of outcome (Primary endpoint: Incidence of an increase in SOFA-Score ≥3 points or death within 28 days)(28 days)
- Prediction of outcome (Death or severe disability after 6 months defined as confinement to bed and inability to wash or dress alone)(6 months)
- Mortality(28 days, 60 days, ICU-stay)
- Death or severe disability after 6 months defined as confinement to bed and inability to wash or dress alone(6 months)
- Safety analysis assessed by documentation of complications and side effects potentially related to iLA activve and/or conventional therapy including complications associated to cannulation and extracorporeal circuit,(6 months)
- Ventilator free days(28 days, ICU stay)
- Early vs. late intervention(6 months)
- Association of the fluid balance to the primary endpoint (Incidence of an increase in SOFA-Score ≥3 points or death within 28 days)(28 days)