• Fatime Hawchar, Ildikó László, Nándor Öveges, Domonkos Trásy, Zoltán Ondrik, and Zsolt Molnar.
• University of Szeged, Department of Anaesthesiology and Intensive Therapy, Szeged H-6725, 6. Semmelweis utca, Hungary. Electronic address: hawchar.fatime@med.u-szeged.hu.
• J Crit Care. 2019 Feb 1; 49: 172-178.

BackgroundThe aim of this proof of concept, prospective, randomized pilot trial was to investigate the effects of extracorporeal cytokine removal (CytoSorb®) applied as a standalone treatment in patients with septic shock.Methods20 patients with early (<24 h) onset of septic shock of medical origin, on mechanical ventilation, norepinephrine>10 μg/min, procalcitonin (PCT) > 3 ng/mL without the need for renal replacement therapy were randomized into CytoSorb (n = 10) and Control groups (n = 10). CytoSorb therapy lasted for 24 h. Clinical and laboratory data were recorded at baseline (T0), T12, T24, and T48 hours.ResultsOverall SOFA scores did not differ between the groups. In the CytoSorb-group norepinephrine requirements and PCT concentration decreased significantly (norepinephrine: CytoSorb: T0 = 0.54[IQR:0.20-1.22], T48 = 0.16[IQR:0.07-0.48], p = .016; Controls: T0 = 0.43[IQR:0.19-0.64], T48 = 0.25[IQR:0.08-0.65] μg/kg/min; PCT: CytoSorb: T0 median = 20.6[IQR: 6.5-144.5], T48 = 5.6[1.9-54.4], p = .004; Control: T0 = 13.2[7.6-47.8], T48 = 9.2[3.8-44.2]ng/mL). Big-endothelin-1 concentrations were also significantly lower in the CytoSorb group (CytoSorb: T0 = 1.3 ± 0.6, *T24 = 1.0 ± 0.4, T48 = 1.4 ± 0.8, *p = .003; Control: T0 = 1.1 ± 0.7, T24 = 1.1 ± 0.6, T48 = 1.2 ± 0.6 pmol/L, p = .115). There were no CytoSorb therapy-related adverse events.ConclusionsThis is the first trial to investigate the effects of early extracorporeal cytokine adsorption treatment in septic shock applied without renal replacement therapy. It was found to be safe with significant effects on norepinephrine requirements, PCT and Big-endothelin-1 concentrations compared to controls.Trial RegistrationThe study has been registered on ClinicalTrials.gov, under the registration number of NCT02288975, registered 13 November 2014.Copyright © 2018 Elsevier Inc. All rights reserved.

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