Inflammation During ECMO Therapy and ECMO Weaning
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- IL-6 concentration (blood samples)
研究概览
简要总结
The goal of this interventional clinical trial is to compare patients who undergo ECMO therapy for treatment of acute respiratory distress syndrome (ARDS) and a randomized into one of two possible weaning strategy groups.
Group 1: Weaning from ventilator occurs before ECMO weaning.
Group 2: Weaning from ECMO occurs before weaning from ventilator.
This study investigates which one of these strategies is more indulgent for the lung, and leads to less inflammation and therefore less potential side effects and an overall more favourable clinical course.
As a primary criterion, measure of IL-6 in blood samples will beused. As secondary criterions, SOFA score at various time points, ventilation pressures, lung injury score (LIS), length of stay in the intensive care unit, and ventilator-associated pneumonia as well as levels of inflammatory cells and cytokines in both blood samples and bronchoalveolar lavage at different time points will be determined.
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
- None
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
- •Acute respiratory distress syndrome (ARDS) according to the Berlin Definition (PaO2/FiO2 < 100) and treatment with veno-venous ECMO (vvECMO)
- •Hemodynamic stability
- •Lung compliance did not change/improved during the last 24 hours
- •Tidal volume did not change/improved during the last 24 hours with a PEEP of 10 cmH20 or above
- •Consent of the patient or their legal representative
排除标准
- •Age < 18 years
- •Artificial ventilation for more than 7 days prior
- •Patient, legal representative or doctors decided against an unrestricted intensive care treatment
- •Positive pregnancy test at time of screening
- •Cardiac failure requiring veno-arterial ECMO therapy
- •Chronic respiratory insufficiency requiring long-term oxygen treatment
结局指标
主要结局
IL-6 concentration (blood samples)
时间窗: For the duration of the ICU stay, or a maximum of 60 days.
Daily control of above mentioned parameter.
次要结局
- Cytokines and inflammatory cells in bronchoalveolar lavage (IL-1beta, Il-10 and TNF-alpha)(For the duration of the ICU stay, or a maximum of 60 days.)
- Ventilation pressures(For the duration of the artificial ventilation, or a maximum of 60 days.)
- Cytokines and inflammatory cells in blood samples (IL-1beta, Il-10 and TNF-alpha)(For the duration of the ICU stay, or a maximum of 60 days.)
- Length of stay in the intensive care unit(For the duration of the ICU stay, or a maximum of 60 days.)
- SOFA-Score(For the duration of the ICU stay, or a maximum of 60 days at indicated time points as described above..)
- Murray Lung Injury Score (LIS)(For the duration of the ICU stay, or a maximum of 60 days.)
- Ventilator-associated pneumonia(For the duration of the ICU stay, or a maximum of 60 days.)