Randomized, prospective, multicenter, open-label, controlled, parallel-group trial investigating the efficacy of add-on plasma-exchange as an adjunctive strategy against septic shock - 2 (EXCHANGE-2)

脓毒症是一种危及生命的器官功能障碍，由于病理性宿主反应的感染。宿主的反应非常复杂，到目前为止，我们还没有针对这种综合征的特异性治疗策略。治疗性血浆交换（TPE）是一种将两种方法结合在一起的技术。除了有效去除有害的循环介质（如细胞因子）外，它还可以替代消耗的保护蛋白（凝血因子、抗渗透因子）。现有的文献（尽管大部分是不受控制的）支持TPE可能改善血流动力学甚至可能改善生存率的假设。为了分析这些方面，我们设计了一项多中心随机对照临床试验（mRCT， 22个德国中心），测试TPE在早期（发病< 24h）和严重（去甲肾上腺素> 0.4 ug/kg/min）感染性休克中的应用。该研究的主要结果是28天死亡率，功率分析显示总分组规模为262例患者。此外，我们将评估许多替代次要终点。

Sepsis is a life-threatening organ dysfunction due a a pathological host response to an infection. The host response is very complex and so far, we have no specific treatment strategy that targets this hallmark of the syndrome. Therapeutic plasma exchange (TPE) is a technique that combines two approaches in one procedure. Besides the efficient removal of harmful circulating mediators (such as cytokines) it can also replace consumed protective proteins (coagulation factors, anti-permeability factors). The available literature (although mostly uncontrolled) supports the hypothesis that TPE might improve hemodynamics and probably even survival. To analyze these aspects we designed a multicentric randomized controlled clinical trial (mRCT, 22 German centers)) testing the use of TPE in early (onset < 24h) and severe (norepinephrine > 0.4 ug/kg/min) septic shock. The primary outcome of the study is the 28-day mortality and power analysis revealed a total group size of 262 patients. Additionally, we will assess many surrogate secondary endpoints.