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      A multicenter randomized controlled study of an extracorporeal cytokine hemoadsorption device in septic patients

      , 1 , 2 , 3 , 4 , 5 , 6 , 7 , 8 , 2 , 1 , 9

      Critical Care

      BioMed Central

      33rd International Symposium on Intensive Care and Emergency Medicine

      19-22 March 2013

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          Abstract

          Introduction A novel sorbent hemoadsorption device for cytokine removal (CytoSorbents, USA) was developed and successfully tested in animal models of sepsis. The experience in the clinical setting is still limited to case reports. In this first clinical trial, we tested the hypothesis that treatment with sorbent hemoadsorption could safely and effectively reduce cytokines in septic patients with acute lung injury (ALI). Methods Ventilated patients fulfilling the criteria for severe sepsis and ALI were enrolled in this multicenter randomized, controlled, open-label study comparing standard of care with or without hemoperfusion treatment. Primary endpoints were safety and IL-6 reduction. Treated patients underwent hemoperfusion at flow rates of ~200 to 3003ml/ minute for 6 hours per day for 7 consecutive days. The overall mean reduction in individual plasma cytokines for the control and treatment groups during the treatment period was calculated using a generalized linear model. Results Forty-three patients (18 treated, 25 control) completed the study and were further analyzed. Incidence of organ dysfunction at enrollment (treatment vs. control) was: septic shock (94% vs. 100%, P = 0.42), acute respiratory distress syndrome (67% vs. 56%, P = 0.33), and renal failure (39% vs. 24%, P = 0.54). During 115 treatments no serious device-related adverse events occurred. On average, there were no changes in hematology and other blood parameters except for a modest reduction in platelet count (<10%) and albumin (<5%) with treatment. Hemoperfusion decreased IL-6 blood concentration significantly (-49.1%, P = 0.01), with similar reductions of MCP-1 (-49.5%, P = 0.002), IL-1ra (-36.5%, P = 0.001), and IL-8 (-30.2%, P = 0.002). The 28-day mortality (28% vs. 24% control, P = 0.84) and 60-day mortality (39% vs. 32% control, P = 0.75) did not differ significantly between the two studied groups. Conclusion In this first clinical study of a novel sorbent hemoadsorption device in patients with severe sepsis and ALI, the device appeared to be safe and decreased the blood concentration of several cytokines. Further research is needed to study the effect of the device on the clinical outcome of septic patients.

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          Author and article information

          Conference
          Crit Care
          Crit Care
          Critical Care
          BioMed Central
          1364-8535
          1466-609X
          2013
          19 March 2013
          : 17
          : Suppl 2
          : P62
          Affiliations
          [1 ]University Medical Center Schleswig-Holstein, Campus Kiel, Germany
          [2 ]University of Leipzig, Germany
          [3 ]Charité University Hospital Campus Virchow-Klinikum, Berlin, Germany
          [4 ]RWTH University Hospital Aachen, Germany
          [5 ]HELIOS Klinikum, Erfurt, Germany
          [6 ]University of Bonn, Germany
          [7 ]University Hospital Göttingen, Germany
          [8 ]Campus Charité Mitte and Campus Charité Virchow-Klinikum, Charité-University Medicine Berlin, Germany
          [9 ]Vivantes Klinikum im Friedrichshain, Berlin, Germany
          Article
          cc12000
          10.1186/cc12000
          3643068
          Copyright ©2013 Schädler et al.; licensee BioMed Central Ltd.

          This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

          33rd International Symposium on Intensive Care and Emergency Medicine
          Brussels, Belgium
          19-22 March 2013
          Categories
          Poster Presentation

          Emergency medicine & Trauma

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