跳至主要内容
临床试验/NCT04391920
NCT04391920已完成不适用

Registry of CytoSorb Therapy in COVID-19 ICU Patients (CTC REGISTRY): Registry of Patient-level Clinical Data on CytoSorb Hemoadsorption Provided Via Integration of the CytoSorb Device Into Extracorporeal Membrane Oxygenation (ECMO), Continuous Renal Replacement Therapy (CRRT), or Hemoperfusion Extracorporeal Circuits in COVID-19 ICU Patients

CytoSorbents, Inc7 个研究点 分布在 1 个国家目标入组 138 人开始时间: 2020年8月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
138
试验地点
7
主要终点
ICU mortality

研究概览

简要总结

The CTC Registry collects patient-level clinical data on CytoSorb hemoadsorption provided to COVID-19 ICU patients via integration of the CytoSorb device into ECMO, CRRT, or hemoperfusion extracorporeal circuits. The intent of the registry is to gain understanding on how CytoSorb hemoadsorption provides clinical benefit to COVID-19 ICU patients.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Confirmed COVID-19
  • Provision of CytoSorb therapy per Instructions for Use (IFU) of the CytoSorb device.

排除标准

  • CytoSorb therapy for diseases other than COVID-19
  • Survival unlikely within 24 hours (for prospectively enrolled patients)

结局指标

主要结局

ICU mortality

时间窗: From the date of start of CytoSorb use until the date of ICU discharge or date of death, whichever comes first, assessed up to 1 year

次要结局

  • Duration of mechanical ventilatory support after start of CytoSorb(From the date of start of CytoSorb use until the date of cessation of mechanical ventilatory support or date of death, which ever comes first, assessed up to 1 year)
  • Change in serum concentrations of inflammatory biomarkers after start of CytoSorb(From the day before start of CytoSorb use until the day after cessation of CytoSorb use)
  • Duration of pharmacologic hemodynamic support after start of CytoSorb(From the date of start of CytoSorb use until the date of cessation of pharmacologic hemodynamic support or date of death, which ever comes first, assessed up to 1 year)
  • Change in Pa02/Fi02 ratio after start of CytoSorb(From the day before start of CytoSorb use until the day after cessation of CytoSorb use)
  • Duration of ECMO after start of CytoSorb(From the date of start of CytoSorb use until the date of cessation of ECMO or date of death, which ever comes first, assessed up to 1 year)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (7)

Loading locations...

相似试验

Registry of CytoSorb Therapy in COVID-19 ICU Patients | 临床试验