Evaluating the Use of Polymyxin B Hemoperfusion in a Randomized Controlled Trial of Adults Treated for Endotoxemia and Septic Shock
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 450
- 试验地点
- 40
- 主要终点
- Mortality
研究概览
简要总结
To compare the safety and efficacy of the PMX cartridge based on mortality at 28-days in subjects with septic shock who have high levels of endotoxin and are treated with standard medical care plus use of the PMX cartridge, versus subjects who receive standard medical care alone.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Hypotension requiring vasopressor support
- •The subject must have received intravenous fluid resuscitation
- •Documented or suspected infection
- •Endotoxin Activity Assay ≥ 0.60 EAA units
- •Evidence of at least 1 new onset organ dysfunction
排除标准
- •Inability to achieve or maintain a minimum mean arterial pressure (MAP) of 65mmHg
- •Subject has end stage renal disease and requires chronic dialysis
- •There is clinical support for non-septic shock
- •Subject has had chest compressions as part of CPR
- •Subject has had an acute myocardial infarction (AMI)
- •Subject has uncontrolled hemorrhage
- •Major trauma within 36 hours of screening
- •Subject has severe granulocytopenia
- •HIV infection with a last known or suspected CD4 count of <50/mm3
- •Subject has sustained extensive third-degree burns
- •Body weight < 35 kg (77 pounds)
- •Known hypersensitivity to polymyxin B
- •Subject has known sensitivity or allergy to heparin
- •Subject has screening MOD score of ≤9
研究组 & 干预措施
Control
Standard medical care for septic shock
干预措施: Standard medical care for septic shock (Other)
Treatment
Two (2) PMX cartridges will be administered approximately 24 hours apart plus standard medical care for septic shock
干预措施: TORAYMYXIN PMX-20R (PMX cartridge) (Device)
Treatment
Two (2) PMX cartridges will be administered approximately 24 hours apart plus standard medical care for septic shock
干预措施: Standard medical care for septic shock (Other)
结局指标
主要结局
Mortality
时间窗: 28 days
Compare mortality at 28 days in subjects treated with standard medical care plus PMX cartridge, versus subjects who received standard medical care alone
次要结局
未报告次要终点