Efficacy of PEAF for Septic Shock With Multiple Organ Dysfunction Syndrome in ICU:A Multicenter,Open-Parallelled ,Randomized and Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 168
- 试验地点
- 12
- 主要终点
- All-cause mortality within 28 days after randomization
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of coupled therapeutic plasma exchange adsorption diafiltration (PEAF )for treating septic shock with multiple organ dysfunction syndrome patients in ICU.
详细描述
Septic shock with multiple organ dysfunction syndrome (MODS) is a life-threatening clinical condition due to coagulant disorder immunoparalysis to infection. For this reason the extracorporeal therapies for the treatment of septic shock with MODS have become widespread in the ICU and, at the same time, new extracorporeal depurative techniques have been developed for the removal of inflammatory mediators. One of these techniques is therapeutic plasma exchange (TPE) that remove pathologically elevated cytokines and simultaneously to replace protective plasmatic factors. other techniques is coupled plasma-filtration adsorption (CPFA) that uses a sorbent once the separation between plasma and blood has been obtained with a plasma filter. The others is Plasma dialysis filtration(PDF) that can remove inflammatory mediators for patients with multiple organ dysfunction syndrome.The purpose of this study is to evaluate the efficacy of PEAF (coupled therapeutic plasma exchange adsorption diafiltration )for treating septic shock with multiple organ dysfunction syndrome patients in ICU.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age, gender: 18-75 years old, male or female;
- •basic conditions: 20 ≤ APACHE II score ≤ 35 points and 10 ≤ Sequential Organ Failure Assessment(SOFA)≤ 18 points;
- •septic shock : On the basis of sepsis, after adequate fluid resuscitation, sustained hypotension requires maintenance of vasoactive drugs, mean arterial pressure（MAP）≥ 60 mmHg and Lactate ≥ 2.0 mmol/L; MODS: if the patient's SOFA score is ≥2 points, it means there is organ dysfunction. When the patient has two or more organ dysfunctions, it is MODS.
排除标准
- •can not remove the cause (surgical patients refused surgery, pan drug resistant infection without drug use)
- •Allergic to AMPLYA™ series
- •Presence of relative or absolute contraindications to PFA
- •MODS caused by severe liver disease
- •malignant tumors
- •Chronic end-stage disease (predicted to survive no more than one month)
- •Maternal and possibly pregnant women
- •participated in drug clinical trials within three months
- •Admission from an other ICU where the patient remained for more than 24 hours
结局指标
主要结局
All-cause mortality within 28 days after randomization
时间窗: 28 days after randomization
efficacy
次要结局
- free hours of vasoactive drugs from randomization(14 days after randomization)
- All-cause mortality within 90 days from randomization(90 days from randomization)