"Analyses on the Effectiveness and Technical Optimization of Therapeutic Plasma Exchange for Patients With Septic Shock, With Special Emphasis on Influencing the Kidney, Liver and Nervous System Through the Extracorporeal Therapy"
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- SOFA score ≥ 2 Punkte
研究概览
简要总结
Therapeutic plasma exchange (TPE) should used for patients with septic shock in a controlled, prospective study focusing on the organ functions of the patients.
详细描述
Therapeutic plasma exchange (TPE) should used for patients with septic shock in a controlled, prospective study.
Investigators will study three groups:
- untreated control group;
- TPE group, plasma separation carried out by filtration;
- TPE group, plasma separation carried out by centrifugation.
All treated patients should treated two (minimal) to five times by TPE, depending on the need of norephinephrine for the therapy. For each session 40 ml/kg body weight plasma should be exchange. Fluid resuscitation will be done with fresh frozen plasma. The study will focusing on the organ functions of the patients, especially liver-, kidney- and nervous function and also displayed in the SOFA score on study days 3 and 7.
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
- Single (Participant)
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
- •Septic shock, beginning of shock < 24 hours
排除标准
- •Participation in an another clinical trial within the last 30 days
- •Participation in this study at an earlier date
- •Simultaneous participation in another clinical trial
- •Pregnancy
- •Unpredictable Bleeding (over 2 erythrocyte concentrates daily)
- •Polyneuropathy (known before the beginning of sepsis)
结局指标
主要结局
SOFA score ≥ 2 Punkte
时间窗: day 7
SOFA: Sepsis-related Organ Failure Assessment score
次要结局
- 28-day survival(day 28)
- Hospital survival(1 year)
研究者
Dr. Martin Sauer, MD
PD Dr. med. habil.; MD
University of Rostock