Haertel Franz, Lehmann Thomas, Heller Tabitha, Fritzenwanger Michael, Pfeifer Ruediger, Kretzschmar Daniel, Otto Sylvia, Bogoviku Jurgen, Westphal Julian, Bruening Christiane, Gecks Thomas, Kaluza Mirko, Moebius-Winkler Sven, Schulze P Christian
Department of Cardiology and Intensive Care, University Hospital Jena, Am Klinikum 1, 07747 Jena, Germany.
Center of Clinical Studies, University Hospital Jena, Salvador-Allende-Platz 27, 07747 Jena, Germany.
J Clin Med. 2023 Jul 25;12(15):4893. doi: 10.3390/jcm12154893.
Cardiogenic shock and arrest present as critical, life-threatening emergencies characterized by severely compromised tissue perfusion and inadequate oxygen supply. Veno-arterial extracorporeal membrane oxygenation (VA-ECMO) serves as a mechanical support system for patients suffering shock refractory to conventional resuscitation. Despite the utilization of VA-ECMO, clinical deterioration due to systemic inflammatory response syndrome (SIRS) resulting from the underlying shock and exposure of blood cells to the artificial surfaces of the ECMO circuit may occur. To address this issue, cytokine adsorbers offer a valuable solution by eliminating blood proteins, thereby controlling SIRS and potentially improving hemodynamics. Consequently, a prospective, randomized, blinded clinical trial will be carried out with ECMOsorb.
ECMOsorb is a single-center, controlled, randomized, triple-blinded trial that will compare the hemodynamic effects of treatment with a VA-ECMO in combination with a cytokine adsorber (CytoSorb, intervention) to treatment with VA-ECMO only (control) in patients with cardiogenic shock (with or without prior cardiopulmonary resuscitation (CPR)) requiring extracorporeal, hemodynamic support. Fifty-four patients will be randomized in a 1:1 fashion to the intervention or control group over a 36-month period. The primary endpoint of ECMOsorb is the improvement of the Inotropic Score (IS) 72 h after the intervention. Prognostic indicators, including mortality rates, hemodynamic parameters, laboratory findings, echocardiographic assessments, quality of life measurements, and clinical parameters, will serve as secondary outcome measures. The safety evaluation encompasses endpoints such as air embolisms, allergic reactions, peripheral ischemic complications, vascular complications, bleeding incidents, and stroke occurrences.
The ECMOsorb trial seeks to assess the efficacy of a cytokine adsorber (CytoSorb; CytoSorbents Europe GmbH, Berlin, Germany) in reducing SIRS and improving hemodynamics in patients with cardiogenic shock who are receiving VA-ECMO. We hypothesize that a reduction in cytokine levels can lead to faster weaning from inotropic and mechanical circulatory support, and ultimately to improved recovery.
心源性休克和心脏骤停是危急的、危及生命的紧急情况，其特征是组织灌注严重受损和氧气供应不足。静脉-动脉体外膜肺氧合（VA-ECMO）是一种为传统复苏治疗无效的休克患者提供机械支持的系统。尽管使用了VA-ECMO，但由于潜在休克导致的全身炎症反应综合征（SIRS）以及血细胞与ECMO回路的人工表面接触，仍可能发生临床恶化。为解决这一问题，细胞因子吸附器通过清除血液蛋白提供了一种有价值的解决方案，从而控制SIRS并可能改善血流动力学。因此，将使用ECMOsorb进行一项前瞻性、随机、双盲临床试验。
ECMOsorb是一项单中心、对照、随机、三盲试验，将比较在需要体外血流动力学支持的心源性休克患者（有或无既往心肺复苏（CPR））中，VA-ECMO联合细胞因子吸附器（CytoSorb，干预组）治疗与仅使用VA-ECMO治疗（对照组）的血流动力学效果。在36个月的时间内，54名患者将以1:1的比例随机分为干预组或对照组。ECMOsorb的主要终点是干预后72小时内变力性评分（IS）的改善。包括死亡率、血流动力学参数、实验室检查结果、超声心动图评估、生活质量测量和临床参数在内的预后指标将作为次要结局指标。安全性评估包括空气栓塞、过敏反应、外周缺血并发症、血管并发症、出血事件和中风发生等终点。
ECMOsorb试验旨在评估细胞因子吸附器（CytoSorb；欧洲CytoSorbents有限公司，柏林，德国）在降低接受VA-ECMO的心源性休克患者的SIRS和改善血流动力学方面的疗效。我们假设细胞因子水平的降低可导致更快地停用正性肌力药物和机械循环支持，并最终改善恢复情况。
