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
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
干预措施: Prismaflex membrane (Device)
Control
干预措施: Blood tests (Biological)
Experimental
干预措施: Oxiris membrane (Device)
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
