Impact of a VA–ECMO in Combination with an Extracorporeal Cytokine Hemadsorption System in Critically Ill Patients with Cardiogenic Shock–Design and Rationale of the ECMOsorb Trial

GND
1201740797
ORCID
0000-0002-4883-5176
Zugehörigkeit
Department of Cardiology and Intensive Care, University Hospital Jena, Am Klinikum 1, 07747 Jena, Germany
Haertel, Franz;
GND
1216191093
Zugehörigkeit
Center of Clinical Studies, University Hospital Jena, Salvador-Allende-Platz 27, 07747 Jena, Germany
Lehmann, Thomas;
GND
1159591911
Zugehörigkeit
Center of Clinical Studies, University Hospital Jena, Salvador-Allende-Platz 27, 07747 Jena, Germany
Heller, Tabitha;
GND
121444872
Zugehörigkeit
Department of Cardiology and Intensive Care, University Hospital Jena, Am Klinikum 1, 07747 Jena, Germany
Fritzenwanger, Michael;
GND
1097760758
Zugehörigkeit
Department of Cardiology and Intensive Care, University Hospital Jena, Am Klinikum 1, 07747 Jena, Germany
Pfeifer, Ruediger;
GND
137265611
Zugehörigkeit
Department of Cardiology and Intensive Care, University Hospital Jena, Am Klinikum 1, 07747 Jena, Germany
Kretzschmar, Daniel;
GND
131973150
Zugehörigkeit
Department of Cardiology and Intensive Care, University Hospital Jena, Am Klinikum 1, 07747 Jena, Germany
Otto, Sylvia;
GND
1294443062
Zugehörigkeit
Department of Cardiology and Intensive Care, University Hospital Jena, Am Klinikum 1, 07747 Jena, Germany
Bogoviku, Jurgen;
GND
1150868996
Zugehörigkeit
Department of Cardiology and Intensive Care, University Hospital Jena, Am Klinikum 1, 07747 Jena, Germany
Westphal, Julian;
GND
1328396215
Zugehörigkeit
Department of Cardiology and Intensive Care, University Hospital Jena, Am Klinikum 1, 07747 Jena, Germany
Bruening, Christiane;
GND
1033533394
Zugehörigkeit
Department of Cardiology and Intensive Care, University Hospital Jena, Am Klinikum 1, 07747 Jena, Germany
Gecks, Thomas;
GND
1322766606
Zugehörigkeit
Department of Cardiothoracic Surgery, University Hospital Jena, Am Klinikum 1, 07747 Jena, Germany
Kaluza, Mirko;
GND
136433057
Zugehörigkeit
Department of Cardiology and Intensive Care, University Hospital Jena, Am Klinikum 1, 07747 Jena, Germany
Moebius-Winkler, Sven;
GND
121635244
ORCID
0000-0001-9442-7141
Zugehörigkeit
Department of Cardiology and Intensive Care, University Hospital Jena, Am Klinikum 1, 07747 Jena, Germany
Schulze, P. Christian

Background: 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. Methods and Study Design: 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. Conclusions: 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.

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