Prospective, Randomized, Single-center, Open-label, Parallel-group Trial Investigating the Efficacy of Therapeutic Plasma Exchange as an Adjunctive Strategy Against Early Septic Shock - Effect on Hemodynamics and Biochemical Markers
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Norepinephrine dose
研究概览
简要总结
Sepsis is defined by the occurrence of critical organ dysfunction in the context of infection. Unfortunately, its incidence appears to be rising, and the mortality of septic shock remains extraordinary high (> 60%). Death in sepsis arises from shock and multi organ dysfunction that are - at least in part - triggered by an inadequate response of the host's immune system to the infection. Given the injurious role of 1) this overwhelming immune response and 2) the consumption of protective plasmatic factors (e.g. vWF cleaving proteases, hemostatic factors etc.) while the disease is progressing the investigators hypothesize that early therapeutic plasma exchange (TPE) in the most severely ill individuals might improve hemodynamics, oxygenation and ultimately survival. This therapeutic strategy combines 2 major aspects in 1 procedure: 1. removal of harmful circulating molecules and 2. replacement of protective plasma proteins. The investigators designed the EXCHANGE trial to analyze in a randomized fashion the benefit of TPE as an add-on treatment to state of the art standard sepsis care. Only patients with early septic shock (< 24 hrs) and high catecholamine doses (norepinephrine > 0.4 ug/kg body weight/min) will be included. Those in the treatment group will receive 1 TPE within 2 hours following randomization. The primary outcome is norepinephrine dose 6 hrs after randomization. The recruitment period is 2 years and will be performed at the Hannover medical School University hospital in Germany. Secondary endpoints (including organ dysfunction as well as biochemical markers of inflammation and coagulation) will be assessed on day 1-8 and day 28 after TPE.
The investigators hope to demonstrate a potential benefit of an additive treatment approach to improve the outcome of patients suffering from septic shock.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Onset of septic shock within less than 24 hrs
- •Norepinephrine dose of ≥ 0.4 ug/kg/min bodyweight (target mean arterial pressure ≥ 65 mmHg) ≥ 30 min
排除标准
- •Age<18 years and > 80 years
- •Pregnancy
- •Known history of transfusion reactions
研究组 & 干预措施
TPE
additive singular therapeutic plasma Exchange (TPE) using fresh frozen Plasma (FFP) as replacement fluid
干预措施: TPE (Device)
SMT
Standard medical Treatment (SMT) for septic shock following the present surviving sepsis guidelines
结局指标
主要结局
Norepinephrine dose
时间窗: 6 hours after randomization
Vasopressor dose reduction as indicator of shock reversal
次要结局
- Mean Sequential organ failure assessment (SOFA) score(day 1-8 following randomization)
- percent change of ADAMTS-13 activity from baseline(6 hours after randomization)
- percent change of activated Protein C activity from baseline(6 hours after randomization)
- 28 day survival(after 28 days following randomization)
- percent change of permeability factors angiopoietin-1, -2 and sTie-2 from baseline(6 hours after randomization)
研究者
Stahl, Klaus Dr.
Dr. Klaus Stahl, Fellow Gastroenterology and Critical Care Medicine
Hannover Medical School