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)

随机、前瞻性、多中心、开放标签、对照、平行组试验，调查附加血浆置换作为感染性休克辅助策略的功效 - 2 (EXCHANGE-2)

• 批准号: 494551625
• 负责人: Professor Dr. Sascha David
• 金额: --
• 依托单位: Klinik für Gastroenterologie, Hepatologie und Endokrinologie
• 依托单位国家: 德国
• 项目类别: Clinical Trials
• 资助国家: 德国
• 项目状态: 未结题
• 来源: https://gepris.dfg.de/gepris/projekt/494551625?language=en
• 关键词: Randomized; prospective; multicenter; open; label

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.

脓毒症是一种威胁生命的器官功能障碍，由宿主对感染的病理性反应引起。宿主的反应非常复杂，到目前为止，我们还没有针对这种症状的具体治疗策略。治疗性血浆交换(TPE)是一种在一个过程中结合两种方法的技术。除了有效清除有害的循环介质(如细胞因子)外，它还可以取代消耗的保护蛋白(凝血因子、抗渗透因子)。现有文献(尽管大多未加控制)支持TPE可能改善血流动力学，甚至可能改善存活率的假设。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24小时)和严重(去甲肾上腺素)感染性休克(0.4 ug/kg/min)中的应用。这项研究的主要结果是28天的死亡率和功率分析显示，总共有262名患者。此外，我们还将评估许多代理次要终端。