Effects of Hemoperfusion With a Polymyxin B Membrane in Peritonitis With Septic Shock
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 243
- 试验地点
- 36
- 主要终点
- Mortality
研究概览
简要总结
The purpose of this randomized, comparative, open and multi-centre study is to show that two sessions of hemoperfusion with Toraymyxin performed within maximum 36 hours after the surgery of a peritonitis by hollow organ perforation reduce the mortality in patients suffering from septic shock.
详细描述
The mortality rate due to peritonitis associated to a severe sepsis or a septic shock remains high (between 40 and 60% as per the studies). The recent complementary therapies for severe sepsis have been reassessed (strict glycaemic control, substitutive corticotherapy, activated protein C). Early neutralisation of the endotoxaemia related to gram-negative bacilli sepsis in contact with hemoperfusion membrane covered with polymyxin B (Toraymyxin™) may enable reduction of the inflammatory reaction caused by sepsis and improve its prognosis. 30 studies, including 10 randomized studies, have compared hemoperfusion with Toraymyxin™ to the standard treatment, showing an improvement in the patients' haemodynamic state, oxygenation conditions and reduction in mortality. This treatment is commonly used in Japan. However, the studies conducted either include only a limited number of patients or are not randomized prospective studies. The post-hoc analysis of a recent randomized study conducted on a limited number of patients with abdominal septic shock shows a significant reduction in mortality after factor adjustment. Though the side effects of such a treatment are limited, its cost is high. Hence, extensive prospective studies are necessary to confirm its effectiveness.
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
- •Confirmed community or nosocomial acquired peritonitis due to organ perforation
- •Septic shock requiring catecholamine infusion started or maintained 2 hours after surgery
排除标准
- •Pregnancy
- •No severity criteria within the 8 hours following surgery
- •Neutropenia due to chemotherapy or malignancy
- •Abdominal sepsis without peritonitis
- •Mesenteric ischemia without perforation
- •Peritonitis due to appendicitis
- •Perforation linked to trauma
- •Cirrhosis child C
- •Impossibility to use heparin
- •Prolonged cardiac arrest within 72h before surgery
- •Terminal disease diagnosed during surgery
- •Moribund subjects
研究组 & 干预措施
Standard therapy
Standard therapy in the ICU including but not limited to: antibiotic therapy, nutrition, fluid challenge, vasopressors, hemodynamic monitoring, organ support in the ICU including mechanical ventilation, renal replacement therapy when appropriate
干预措施: standard therapy (Device)
Hemoperfusion
standard therapy + 2 sessions of hemoperfusion within the first 24 hours
干预措施: standard therapy (Device)
Hemoperfusion
standard therapy + 2 sessions of hemoperfusion within the first 24 hours
干预措施: hemoperfusion (Device)
结局指标
主要结局
Mortality
时间窗: 28 days
次要结局
- number of participants with adverse events related to hemoperfusion technique including anticoagulation therapy such as bleeding (type and number of blood transfusion)(day1-day4)
- mortality between the two groups at 7 dayx, 14 days, 21 days and 90 days(90 days)
- organ failure assessed by SOFA score(day 3)
- delay to withdraw catecholamine after initial shock(day 1-day 28)