Cytokine Adsorption in Sepsis and Acute Kidney Injury
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 124
- 试验地点
- 2
- 主要终点
- RIFLE stadium L or E after acute kidney injury related to sepsis
研究概览
简要总结
Aim of the study is to reduce the incidence of RIFLE stadium L and E after acute kidney injury in patients with severe sepsis/septic shock
详细描述
Patient with proved severe sepsis/septic shock, treated in accordance to actual sepsis guidelines, who develope akute kidney injury (RIFLE I) or kidney failure (RIFLE F), were randomized in two groups.
One group is treated with CVVHD/ local citrat anticoagulation (standart clinical practice).
The other group ist treated with an additional cytokine adsorber ( 300ml CytoSorb device, 3804606CE01)
CytoSorb therapy is performed for 24h, then the adsorber is changed into a new device.
Cytosorb therapy is stopped, when Interleukin 6 leves drop below 1000 pg/ml in patient serum.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •severe sepsis or septic shock according to ESICM guidelines not older than 24 h
排除标准
- •preexisting renal disease KDIGO stadium 4 and 5
结局指标
主要结局
RIFLE stadium L or E after acute kidney injury related to sepsis
时间窗: 3 months
次要结局
- SOFA score(3 months)
- length of renal replacement therapy(3 months)
- mortality(3 months)
- cumulative dose of vasopressor support(4 weeks)
研究者
Guenther_Edenharter
Dr.med.
Technical University of Munich