Prospective Quality Assurance Study for the Application of Cytosorb® in Patients With Cytokine Storm, Rhabdomyolysis and Acute Liver Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- Change (percentage) in myoglobin measured pre- and post-CytoSorb® (extracorporeal) in intensive care patients with rhabdomyolysis
研究概览
简要总结
The mortality of critically ill patients is persistently high and requires targeted therapy of pathophysiological disorders. One approach to optimize therapy is the use of the cytokine adsorber Cytosorb®, which has a CE certification for the indications hyperinflammation, rhabdomyolysis and liver failure and is therefore frequently used in patients with sepsis, polytrauma and acute liver failure. Although few clinical data describe the efficiency mostly retrospectively, there are no data on real-time elimination performance and saturation kinetics during the course of treatment. These questions should be answered by the present study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •intensive care therapy
- •hyperinflammation or acute liver dysfunction or rhabdomyolysis
- •need of continuous renal replacement therapy
- •treatment with Cytosorb (decision of the attending physician)
排除标准
- •other reasons for Cytosorb application
研究组 & 干预措施
Cytosorb therapy
blood samples are taken before and after the cytokine adsorber at given times
干预措施: Cytosorb therapy (Device)
结局指标
主要结局
Change (percentage) in myoglobin measured pre- and post-CytoSorb® (extracorporeal) in intensive care patients with rhabdomyolysis
时间窗: 12 hours
Measurement of myoglobin before and after the filter at different times.
Change (percentage) in different cytokines (measured as a cytokine panel) measured pre- and post-CytoSorb® (extracorporeal) in intensive care patients with hyperinflammation
时间窗: 12 hours
Measurement of a cytokine panel (20 different cytokines in one panel) before and after the filter at different times.
Change (percentage) in bile acids (measured as a panel) measured pre- and post-CytoSorb® (extracorporeal) in intensive care patients with acute liver failure
时间窗: 12 hours
Measurement of bile acids before and after the filter at different times.
次要结局
- Change (percentage) in norepinephrine demand before and after the use of CytoSorb®(2 years)
- Change ( percentage ) of liver toxic substances (e.g. bile acids) in patients´ blood due to the use of CytoSorb®(2 years)
- Change ( percentage ) of myoglobin in patients´ blood due to the use of CytoSorb®(2 years)
- Difference (percentage) between predicted mortality and real mortality of patients treated with CytoSorb®(2 years)
研究者
Michael Zoller MD
Principle Investigator
Ludwig-Maximilians - University of Munich