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).
【저자키워드】 COVID-19, Critical care, adult intensive &, respiratory medicine (see thoracic medicine), 【초록키워드】 Treatment, Efficacy, ARDS, protocol, Trial, Open-label, randomised, severe COVID-19, acute respiratory distress syndrome, IL-6, V-V ECMO, Ethics, interleukin-6, Intervention, cytokine, outcome, extracorporeal membrane oxygenation, Critically ill, Germany, Patient, multicentre, respiratory, university, Intensive, Critical, critically ill patients, acute respiratory distress, Adsorption, Thoracic, Extracorporeal, IL-6 levels, respiratory distress, Support, Critically ill patient, parallel group, syndrome, veno-venous extracorporeal membrane oxygenation, ethical committee, approach, Course, include, approved, elevated, nine, treated, reducing, evaluate the effect, 1:1, baseline, hypothesise, IL-6 level, randomised controlled, 【제목키워드】 Severe COVID-19 pneumonia, protocol, Trial, Open-label, randomised, Intervention, cytokine, Patient, membrane, multicentre, Adsorption,