Cytokine adsorption in patients with severe COVID-19 pneumonia requiring extracorporeal membrane oxygenation: protocol for a randomised, controlled, open-label intervention, multicentre trial

Marina Rieder, Fabian Schubach, Claudia Schmoor, Caroline von Spee-Mayer, Tobias Wengenmayer, Jonathan Rilinger, Dawid Staudacher, Christoph Bode, Daniel Duerschmied, Alexander Supady, Marina Rieder, Fabian Schubach, Claudia Schmoor, Caroline von Spee-Mayer, Tobias Wengenmayer, Jonathan Rilinger, Dawid Staudacher, Christoph Bode, Daniel Duerschmied, Alexander Supady

Abstract

Introduction: Veno-venous extracorporeal membrane oxygenation (V-V ECMO) is a last resort treatment option in patients with severe COVID-19 related acute respiratory distress syndrome (ARDS). Mortality in these critically ill patients is high. Elevated interleukin-6 (IL-6) levels in these severe courses are associated with poor outcome. Extracorporeal cytokine adsorption is an approach to lower elevated IL-6 levels. However, there is no randomised controlled data on the efficacy of cytokine adsorption and its effect on patient outcome in severe COVID-19 related ARDS requiring V-V ECMO support.

Methods and analysis: We here report the protocol of a 1:1 randomised, controlled, parallel group, open-label intervention, superiority multicentre trial to evaluate the effect of extracorporeal cytokine adsorption using the CytoSorb device in severe COVID-19 related ARDS treated with V-V ECMO. We hypothesise that extracorporeal cytokine adsorption in these patients is effectively reducing IL-6 levels by 75% or more after 72 hours as compared with the baseline measurement and also reducing time to successful V-V ECMO explantation. We plan to include a total of 80 patients at nine centres in Germany.

Ethics and dissemination: The protocol of this study was approved by the ethical committee of the University of Freiburg as the leading institution (EK 285/20). Additional votes will be obtained at all participating centres.

Trial registration numbers: NCT04385771 and DRKS 00021248.

Keywords: COVID-19; adult intensive & critical care; respiratory medicine (see thoracic medicine).

Conflict of interest statement

Competing interests: AS and DD received speakers’ honoraria from CytoSorbents, the manufacturer of the CytoSorb device. AS also received a research grant from CytoSorbents. For this grant, the company CytoSorbents receives no consideration.

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Participant timeline. Schedule for enrolment, interventions and assessments. V-V ECMO, veno-venous extracorporeal membrane oxygenation.

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