跳至主要内容
临床试验/NCT04886180
NCT04886180已完成不适用

Evaluation of Oxiris Membrane as a Treatment for Ischemia-reperfusion Syndrome in Cardiogenic Shock Treated With Extracorporeal Life Support (ECMO/ECLS): A Randomized Pilot Study ECMORIX

Centre Hospitalier Universitaire Dijon1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年5月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Plasma concentration of lipopolysaccharides

研究概览

简要总结

The Oxiris membrane is an AN-69 membrane whose surface is treated with polyethyleneimine (PEI) grafted with heparin. This property allows the removal of lipopolysaccharide and cytokines from the blood. During septic shock, this membrane has shown its effectiveness and made it possible to decrease the doses of vasopressors administered, thus limiting the negative consequences of their use (low mesenteric flow in particular). Moreover, the literature suggests that the use of the Oxiris membrane does not lead to side effects or specific and serious complications, in comparison with conventional extra-renal purification membranes. To our knowledge (Pubmed, clinicaltrial) there are no data in patients in cardiogenic shock assisted by ECLS.

The research hypothesis is that the early addition of an Oxiris membrane to the ECLS circuit allows the removal of lipopolysaccharides and pro-inflammatory cytokines, thus controlling the inflammatory cascade and limiting vasoplegia and organ failure.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Trusted person or relative who has given oral consent or emergency consent
  • •Person of legal age
  • •Patient receiving ECLS for refractory cardiogenic shock requiring continuous renal replacement therapy
  • •Included within 12 hours of ECLS initiation

排除标准

  • •Person not affiliated to national health insurance
  • •Person under legal protection (curatorship, guardianship)
  • •Person under court order
  • •Pregnant or breastfeeding woman
  • •Severe hemorrhage under ECLS

研究组 & 干预措施

Control

Active Comparator

干预措施: Prismaflex membrane (Device)

Control

Active Comparator

干预措施: Blood tests (Biological)

Experimental

Experimental

干预措施: Oxiris membrane (Device)

Experimental

Experimental

干预措施: Blood tests (Biological)

结局指标

主要结局

Plasma concentration of lipopolysaccharides

时间窗: 24 hours after addition of the membrane

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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