Clin Res Cardiol (2022). https://doi.org/10.1007/s00392-022-02002-5

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
F. Härtel1, T. Lehmann2, T. Heller2, M. Fritzenwanger1, R. Pfeifer1, D. Kretzschmar1, M. Kaluza3, S. Möbius-Winkler1, C. Schulze1, für die Studiengruppe: ECMOsorb
1Klinik für Innere Medizin I - Kardiologie, Universitätsklinikum Jena, Jena; 2Zentrum für Klinische Studien, Universitätsklinikum Jena, Jena; 3Klinik für Herz- und Thoraxchirurgie, Universitätsklinikum Jena, Jena;

BACKGROUND
Cardiogenic shock and arrest are life - threatening emergencies with critically reduced tissue perfusion and oxygen supply. Veno arterial extracorporeal membrane oxygenation (VA - ECMO) technically provides mechanical flow support (pump function) and gas exchange / oxygenation (lung function) at the same time. However, clinical and hemodynamic deterioration due to hyperinflammation caused by the underlying shock and exposure of blood cells to the artificial surfaces of the ECMO circuit may occur leading to prolonged dependency on inotropic and VA - ECMO support. Cytokine adsorbers provide a tool for the elimination of blood proteins to control the systemic inflammatory response and potentially hemodynamic improvement. Therefore, a prospective, randomized, blinded, and adequately powered clinical trial is warranted and will be carried out with ECMOsorb.

METHODS and STUDY DESIGN
ECMOsorb is a controlled, monocenter, randomized, triple - blinded trial. It is designed to compare whether treatment with a VA - ECMO in combination with an extracorporeal cytokine adsorber (intervention) is hemodynamically beneficial in comparison to VA ECMO only (control) in patients with cardiogenic shock (with or without cardiopulmonary resuscitation (CPR)) requiring extracorporeal, hemodynamic support (Figure 1). Within a 24 months period, 54 patients will be randomized in a 1:1 fashion to be either in the intervention or control group (Figure 2). The primary endpoint of ECMOsorb is improvement of the Inotropic Score (IS) 72 hours after VA ECMO initiation. Secondary outcome measures such as mortality, hemodynamic, laboratory, echocardiographic, quality of life, and clinical parameters will serve as surrogate endpoints for prognosis. Safety endpoints include air embolism, allergic reactions, peripheral, ischemic, vascular complications, bleeding, and stroke. The protocol was approved by the institutional review board and ethics committee of the University of Jena (ClinicalTrials.gov registry: NCT05027529).


CONCLUSION
The ECMOsorb trial will investigate on how effective the control of the hyperinflammation via an extracorporeal cytokine adsorber impacts patients with cardiogenic shock under VA ECMO support. The essential goal is an improved hemodynamic stabilization and faster VA -ECMO weaning.









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