CytoSorb Rescue for COVID-19 Patients With Vasoplegic Shock and Multiple Organ Failure: A Prospective, Open-Label, Randomized Controlled Pilot Study.

To investigate the effect of extracorporeal cytokine reduction by CytoSorb (CytoSorbents, Monmouth Junction, NJ) on COVID-19-associated vasoplegic shock. Prospective, randomized controlled pilot study. Eight ICUs at three sites of the tertiary-care university hospital Charité-Universitätsmedizin Berlin. COVID-19 patients with vasoplegic shock requiring norepinephrine greater than 0.2 µg/kg/min, C-reactive protein greater than 100 mg/L, and indication for hemodialysis. Randomization of 1:1 to receive CytoSorb for 3-7 days or standard therapy. To account for inadvertent removal of antibiotics, patients in the treatment group received an additional dose at each adsorber change. The primary endpoint was time until resolution of vasoplegic shock, estimated by Cox-regression. Secondary endpoints included mortality, interleukin-6 concentrations, and catecholamine requirements. The study was registered in the German Registry of Clinical Trials (DRKS00021447). From November 2020 to March 2021, 50 patients were enrolled. Twenty-three patients were randomized to receive CytoSorb and 26 patients to receive standard of care. One patient randomized to cytokine adsorption was excluded due to withdrawal of informed consent. Resolution of vasoplegic shock was observed in 13 of 23 patients (56.5%) in the CytoSorb and 12 of 26 patients (46.2%) in the control group after a median of 5 days (interquartile range [IQR], 4-5 d) and 4 days (IQR, 3-5 d). The hazard ratio (HR) for the primary endpoint, adjusted for the predefined variables age, gender, extracorporeal membrane oxygenation-therapy, or time from shock onset to study inclusion was HR, 1.23 (95% CI, 0.54-2.79); p = 0.63. The mortality rate was 78% in the CytoSorb and 73% in the control group (unadjusted HR, 1.17 [95% CI, 0.61-2.23]; p = 0.64). The effects on inflammatory markers, catecholamine requirements, and the type and rates of adverse events were similar between the groups. In severely ill COVID-19 patients, CytoSorb did not improve resolution of vasoplegic shock or predefined secondary endpoints.

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Déclaration de conflit d'intérêts

Dr. Enghard received honoraria from GlaxoSmithKline and AstraZeneca and filed two patents for novel urinary biomarkers outside the submitted work. Prof. Dr. Treskatsch received research funding and honoraria for workshops and lectures from Orionpharma, Edwards, Amomed, Cytosorbents, and Smith&Nephews all outside the submitted work. Prof. Dr. Spies received grants from Drägerwerk AG. KGaA; German Research Society; German Aerospace Center; Einstein Foundation Berlin; Federal Joint Committee (Gemeinsamer Bundesaussschuss [G-BA]); Inner University grants; Project Management Agency; Non-Profit Promoting Science and Education; European Society of Anesthesiology and Intensive Care; Baxter Deutschland GmbH; Cytosorbents Europe GmbH; Edwards Lifesciences Germany GmbH; Fresenius Medical Care; Grünenthal GmbH; Massimo Europe; Pfizer Pharma GmbH; Georg Thieme Verlag, Dr. F Köhler Chemie GmbH; Sintetica GmbH; Stifterverband für die deutsche Wissenschaft e.V./Philips; Stiftung Charié; Aguettant Deutschland GmbH; AbbVie Deutschland GmbH & KG; Amomed Pharma GmbH; InTouch Health; Copra System GmbH; Correvio GmbH; Max Plank Gesellschaft zur Förderung der Wissenschaften e.V.; Deutsche Gesellschaft für Anästhesiologie & Intensivmedizin; Stifterverband für die Deutsche Wissenschaft e.V./Medtronic; Philipps ElectronicsNederland BV; and the Federal Ministry of Health, (Bundesministerium für Gesundheit [BMG]), the Federal Ministry of Education and Research (Bundesministerium für Bildung und Forschung [BMBF]), German Research Society all outside the submitted work. In addition, Prof. Dr. Spies has different patents. Dr. Khadzhynov received fees for speaking at a symposium organized on behalf of Fresenius Medical Care AG, Germany. The remaining authors have disclosed that they do not have any potential conflicts of interest.