Effect of the CytoSorb Adsorber on Hemodynamic, Immunological and Pharmacokinetic Parameters in Refractory Septic Shock
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Percentage of patients with a reduction of catecholamine dose of at least 25% within the first 48 hours of treatment
研究概览
简要总结
This prospective randomized single center study investigates to what extent the removal of elevated cytokine levels by hemoadsorption has a positive effect on the treatment of patients in septic shock by stabilizing the circulatory situation.
详细描述
The term "sepsis" refers to a clinical syndrome in which a dysregulation of the host's inflammatory reaction to infection leads to a life-threatening of organ dysfunctions. Sepsis and septic shock are major causes of death in intensive care units worldwide.
The clinical picture of septic shock, the most severe form of sepsis, leads to uncontrolled production and release of a large number of proinflammatory cytokines and mediators, the "cytokine storm". Septic shock is accompanied by a massive increase in mortality of up to 60%.
This high mortality rate is due to a lack of current treatment options. The early recognition of the disease and its immediate treatment are decisive for successful therapy and the survival of those affected. The most important therapeutic steps, apart from focus control by antibiotics and surgical intervention, are the stabilization of the affected organ systems, in particular the circulatory system and the respiratory system. As an extracorporeal and non-specific procedure for the interruption of the cytokine storm, hemoadsorption by means of CytoSorb adsorbers may be an intervention, which has already demonstrated its basic effectiveness in the treatment of septic and cardiosurgical patients.
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
- •Refractory septic shock
- •Need for Norepinephrine ≥ 0.25 µg/kg/min
- •IL6 ≥ 1000 ng/l
- •Indication for CRRT
排除标准
- •Sepsis due to pulmonary or urogenital causes
- •Onset of septic shock longer than 36 hours
- •Liver cirrhosis Child Pugh C
- •"do not resuscitate"-order
- •expected survival < 14 days
- •participation in another interventional trial
- •Pregnancy or breastfeeding
- •Lack of consent
结局指标
主要结局
Percentage of patients with a reduction of catecholamine dose of at least 25% within the first 48 hours of treatment
时间窗: 48 hours
Percentage of patients with a reduction of catecholamine dose of at least 25% compared to baseline for at least 6 hours within the first 48 hours of treatment.
次要结局
- ICU length of stay(90 days)
- Time on mechanical ventilation(10 days)
- Cumulative catecholamine dose(10 days)
- Renal replacement therapy(10 days)
- End of septic shock(10 days)
- Overall and ICU mortality(90 days)
- Percentage of patients with a reduction of catecholamine dose of at least 25% within the first 24 hours of treatment(24 hours)
- Change of plasma Interleukin-10 (IL10) level(10 days)
- Change of plasma Procalcitonin (PCT) level(10 days)
- Change of HLA-DR level(10 days)
- Lactate clearance(10 days)
- Serum levels of administered anti-infectives(3 days)
- Change in organ dysfunction(10 days)
- Change of plasma Interleukin-6 (IL6) level(10 days)
- Change of TNF alpha level after ex-vivo stimulation(10 days)