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 Dürschmied, 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.<br><br>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.<br><br>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.<br><br>Trial registration numbers NCT04385771 and DRKS 00021248.
| Medienart: |
E-Book |
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| Erscheinungsjahr: |
2021 |
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| Erschienen: |
London: BMJ ; 2021 Freiburg: Albert-Ludwigs-Universität Freiburg ; 2021 |
| Enthalten in: |
BMJ open - 11, 1 (2021), e043345 |
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| Sprache: |
Englisch |
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| Beteiligte Personen: |
Rieder, Marina [VerfasserIn] |
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| Links: |
nbn-resolving.de [kostenfrei] |
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| Umfang: |
1 Online-Ressource (31 Seiten) |
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| doi: |
10.1136/bmjopen-2020-043345 |
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| Weitere IDs: |
urn:nbn:de:bsz:25-freidok-1942025 FRUB-opus-194202 |
| funding: |
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| Förderinstitution / Projekttitel: |
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| 520 | |a 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.<br><br>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.<br><br>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.<br><br>Trial registration numbers NCT04385771 and DRKS 00021248 | ||
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