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临床试验/NCT01948778
NCT01948778已完成不适用

The Effects of a Polyethyleneimine-coated Membrane (oXiris™) for Hemofiltration Versus Polymyxin B- Immobilized Fibre Column (Toraymyxin™) for Hemoperfusion on Endotoxin Activity and Inflammatory Conditions in Septic Shock- A Randomized Controlled Pilot Study

University of Zurich1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2013年8月1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
38
试验地点
1
主要终点
Measurement of the endotoxin activity 72 hours after treatment initiation

研究概览

简要总结

Septic shock has a high mortality risk despite the availability of various treatments. Endotoxin, that is present in the cell walls of gram-negative bacteria, is a potent trigger of innate immunity. Endotoxin leads to an activation of a cascade with an overwhelming systemic overflow of pro- and anti- inflammatory mediators at the early phase of sepsis with generalized vascular endothelial damage, tissue injury and multi-organ failure.

Extracorporeal blood purification therapies aim to reduce the circulating level of endotoxin. Different extracorporeal blood purification systems are available. The oXiris™ device comprises a surface treated AN69 membrane capable to adsorb a large spectrum of plasma cytokines, such as IL-6 and HMGB1 protein. The positively charged inner surface of the membrane allows absorbing negatively charged bacterial products such as endotoxin. From an historical perspective, filters containing AN69-based membranes have been the most commonly used products for CRRT in the management of critically ill patients and a substantial volume of published data exist.

Another extracorporeal endotoxin removal therapy is the hemoperfusion with ToraymyxinTM (PMX) filter, which is a cartridge selectively removing blood endotoxin. PMX is composed of polymyxin B covalently bonded to polystyrene-derivative fibres. It is well known that the polarity of the polymyxin B antibiotic binds endotoxin and has bactericidal activity. Therefore, the rationale underlying extracorporeal therapy with PMX is to remove circulating endotoxin by adsorption.

  • Trial with medical device

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

  • •Patients with septic shock, defined as 30ml/kg of i.v. fluid administered within a period of 6 hours after initiation of vasopressor therapy with a vasopressor index =3, and at least one of the following criteria: metabolic acidosis, neurologic dysfunction, renal dysfunction, or acute hepatic dysfunction
  • •Male and Female patients =18 years
  • •Endotoxin levels =0.6 IU EAA (measured at ICU admission and repeated 24 hours later in case the initial value is =0.4 and <0.6)

排除标准

  • •Endotoxin levels <0.6 IU EAA
  • •Pregnancy or breast feeding
  • •Neutropenia (circulating neutrophils <500/µl)
  • •Pre-existing immune deficiencies or immune-suppressive therapy, especially corticosteroids
  • •Use of Vasopressin (Pitressin?)
  • •Organ transplantation within the last 12 months
  • •Terminally ill patients classified as "do not resuscitate"
  • •History of sensitivity to polymyxin B or to anticoagulant (heparin) HIT or allergy to heparin
  • •Need for extracorporeal membrane oxygenation (ECMO)

研究组 & 干预措施

oXiris™ filter

Experimental

oXiris™ filter

干预措施: oXiris™ filter (Device)

Toraymyxin Filter

Experimental

Toraymyxin Filter

干预措施: Toraymyxin Filter (Device)

Standard of Care

Other

Standard of Care CRRT if necessary

干预措施: Standard of Care (Device)

结局指标

主要结局

Measurement of the endotoxin activity 72 hours after treatment initiation

时间窗: 72 hours

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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