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
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
oXiris™ filter
干预措施: oXiris™ filter (Device)
Toraymyxin Filter
Toraymyxin Filter
干预措施: Toraymyxin Filter (Device)
Standard of Care
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
