Effect of CytoSorb Adsorber on Hemodynamic and Immunological Parameters in Critical Ill Patients With COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Percentage of patients with a significant stabilization of hemodynamics for at least 24 hours
研究概览
简要总结
This prospective randomized single Center study investigates to what extent the physical elimination of the inflammatory mediators using the CytoSorb adsorber reduces the morbidity of severely and critically ill patients with Covid-19.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •confirmed COVID-19 disease
- •refractory shock with need for norepinephrine ≥ 0.2 μg/kg/min for MAP ≥ 65 mmHg
- •IL6 ≥ 500 ng/l
- •Indication for CRRT or ECMO
排除标准
- •Liver cirrhosis Child Pugh C
- •"do not resuscitate"-order
- •expected survival due to comorbidities < 14 days
- •pregnancy or breastfeeding
- •participation in another interventional trial
研究组 & 干预措施
CytoSorb-Therapy
Therapy of COVID-19 with need for extracorporeal circulation (continuous renal replacement therapy or extracorporeal membrane oxygenation) using standard of care in Addition with hemoadsorption using CytoSorb-Adsorber
干预措施: CytoSorb-Therapy (Device)
Standard of care
Therapy of COVID-19 with need for extracorporeal circulation (continuous renal replacement therapy or extracorporeal membrane oxygenation) using standard of care
结局指标
主要结局
Percentage of patients with a significant stabilization of hemodynamics for at least 24 hours
时间窗: 24 hours
Percentage of patients with a significant stabilization of hemodynamics ("shock reversal"), defined as a significant reduction of the noradrenaline dose (≤ 0.05 µg/kg/min) while maintaining mean arterial pressure ≥ 65 mmHg for at least 24 hours compared to control group
次要结局
- Cumulative catecholamine dose(10 days)
- Time on mechanical ventilation(10 days)
- Change of plasma Procalcitonin (PCT) level(10 days)
- Change of TNF alpha level after ex-vivo stimulation(10 days)
- Lactate clearance(10 days)
- Extracorporeal Membrane Oxygenation(10 days)
- Overall and ICU mortality(90 days)
- Change in organ dysfunction(10 days)
- Renal replacement therapy(10 days)
- ICU length of stay(90 days)
- Change of plasma Interleukin-6 (IL6) level(10 days)
- Change of plasma Interleukin-10 (IL10) level(10 days)
- Change of HLA-DR level(10 days)