S Friesecke1, K Träger2, G A Schittek3, Z Molnar4, F Bach5, K Kogelmann6, R Bogdanski7, A Weyland8, A Nierhaus9, F Nestler10, D Olboeter11, D Tomescu12, D Jacob13, H Haake14, E Grigoryev15, M Nitsch16, A Baumann17, M Quintel18, M Schott19, J T Kielstein20, A Meier-Hellmann21, F Born22, U Schumacher23, M Singer24, J Kellum25, F M Brunkhorst26,27,28. 1. Klinik und Poliklinik für Innere Medizin B, Universitätsmedizin Greifswald, Greifswald, Germany. 2. Kardioanästhesiologie, Universitätsklinikum Ulm, Ulm, Germany. 3. Klinik für Anästhesiologie, Intensivtherapie und Palliativmedizin, Carl-Thiem-Klinikum Cottbus, Cottbus, Germany. 4. Department of Anesthesiology and Intensive Care, University of Szeged, Szeged, Hungary. 5. Klinik für Anästhesiologie, Intensiv‑, Notfallmedizin, Transfusionsmedizin und Schmerztherapie, Evangelisches Krankenhaus Bielefeld, Bielefeld, Germany. 6. Klinik für Anästhesiologie und Intensivmedizin, Hans-Susemihl-Krankenhaus gGmbH, Emden, Germany. 7. Klinik für Anästhesiologie, AG Hämodynamik, Klinikum rechts der Isar TU München, München, Germany. 8. Universitätsklinik für Anästhesiologie/Intensiv‑/Notfallmedizin/Schmerztherapie, Klinikum Oldenburg gGmbH, Carl von Ossietzky Universität, Oldenburg, Germany. 9. Klinik für Intensivmedizin, Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany. 10. Anästhesie und Intensivmedizin, Kliniken Erlabrunn gGmbH, Breitenbrunn, Germany. 11. Anästhesie und Intensivmedizin, Krankenhaus Herzberg, Elbe-Elster-Klinikum GmbH, Herzberg, Germany. 12. Fundeni Clinical Institute, Bucharest, Romania. 13. Klinik für Allgemein‑, Viszeral- und Gefäßchirurgie, Universitätsklinikum Magdeburg, Magdeburg, Germany. 14. Klinik für Kardiologie und Intensivmedizin, Kliniken Maria Hilf GmbH, Mönchengladbach, Germany. 15. Institute for Complex Issues of Cardiovascular Diseases, Kemerovo, Russian Federation. 16. Klinik für Anästhesie, Intensiv‑, Notfallmedizin und Schmerztherapie, Krankenhaus St. Elisabeth und St. Barbara Halle, Halle, Germany. 17. Klinik für Anästhesie, Intensiv‑, Palliativ- und Schmerzmedizin, Berufsgenossensch. Uniklinik Bergmannsheil, Bochum, Germany. 18. Zentrum Anästhesiologie, Rettungs-und Intensivmedizin, Universitätsklinikum Göttingen, Göttingen, Germany. 19. Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie, Klinikum Region Hannover Nordstadt, Hannover, Germany. 20. Medizinische Klinik V, Klinikum Braunschweig, Braunschweig, Germany. 21. Anästhesie, Intensivmedizin und Schmerztherapie, HELIOS Klinikums Erfurt, Erfurt, Germany. 22. Herzchirurgische Klinik und Poliklinik, LMU München, München, Germany. 23. Center for Clinical Studies Jena (ZKS), Jena, Germany. 24. Intensive Care Medicine, University College London, London, UK. 25. Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, USA. 26. Center for Clinical Studies Jena (ZKS), Jena, Germany. Frank.Brunkhorst@med.uni-jena.de. 27. Center for Sepsis Control and Care (CSCC), Jena, Germany. Frank.Brunkhorst@med.uni-jena.de. 28. Department of Anaesthesiology and Intensive Care Medicine, Jena University Hospital, Erlanger Allee 101, 07747, Jena, Germany. Frank.Brunkhorst@med.uni-jena.de.
Abstract
INTRODUCTION: The aim of this clinical registry is to record the use of CytoSorb® adsorber device in critically ill patients under real-life conditions. METHODS: The registry records all relevant information in the course of product use, e. g., diagnosis, comorbidities, course of the condition, treatment, concomitant medication, clinical laboratory parameters, and outcome (ClinicalTrials.gov Identifier: NCT02312024). Primary endpoint is in-hospital mortality as compared to the mortality predicted by the APACHE II and SAPS II score, respectively. RESULTS: As of January 30, 2017, 130 centers from 22 countries were participating. Data available from the start of the registry on May 18, 2015 to November 24, 2016 (122 centers; 22 countries) were analyzed, of whom 20 centers from four countries provided data for a total of 198 patients (mean age 60.3 ± 15.1 years, 135 men [68.2%]). In all, 192 (97.0%) had 1 to 5 Cytosorb® adsorber applications. Sepsis was the most common indication for CytoSorb® treatment (135 patients). Mean APACHE II score in this group was 33.1 ± 8.4 [range 15-52] with a predicted risk of death of 78%, whereas the observed mortality was 65%. There were no significant decreases in the SOFA scores after treatment (17.2 ± 4.8 [3-24]). However interleukin-6 levels were markedly reduced after treatment (median 5000 pg/ml before and 289 pg/ml after treatment, respectively). CONCLUSIONS: This third interim report demonstrates the feasibility of the registry with excellent data quality and completeness from 20 study centers. The results must be interpreted with caution, since the numbers are still small; however the disease severity is remarkably high and suggests that adsorber treatment might be used as an ultimate treatment in life-threatening situations. There were no device-associated side effects.
INTRODUCTION: The aim of this clinical registry is to record the use of CytoSorb® adsorber device in critically illpatients under real-life conditions. METHODS: The registry records all relevant information in the course of product use, e. g., diagnosis, comorbidities, course of the condition, treatment, concomitant medication, clinical laboratory parameters, and outcome (ClinicalTrials.gov Identifier: NCT02312024). Primary endpoint is in-hospital mortality as compared to the mortality predicted by the APACHE II and SAPS II score, respectively. RESULTS: As of January 30, 2017, 130 centers from 22 countries were participating. Data available from the start of the registry on May 18, 2015 to November 24, 2016 (122 centers; 22 countries) were analyzed, of whom 20 centers from four countries provided data for a total of 198 patients (mean age 60.3 ± 15.1 years, 135 men [68.2%]). In all, 192 (97.0%) had 1 to 5 Cytosorb® adsorber applications. Sepsis was the most common indication for CytoSorb® treatment (135 patients). Mean APACHE II score in this group was 33.1 ± 8.4 [range 15-52] with a predicted risk of death of 78%, whereas the observed mortality was 65%. There were no significant decreases in the SOFA scores after treatment (17.2 ± 4.8 [3-24]). However interleukin-6 levels were markedly reduced after treatment (median 5000 pg/ml before and 289 pg/ml after treatment, respectively). CONCLUSIONS: This third interim report demonstrates the feasibility of the registry with excellent data quality and completeness from 20 study centers. The results must be interpreted with caution, since the numbers are still small; however the disease severity is remarkably high and suggests that adsorber treatment might be used as an ultimate treatment in life-threatening situations. There were no device-associated side effects.
Entities:
Keywords:
Cytokines; Extracorporeal life support; Inflammation; Intensive care units; Sepsis
Authors: Ganesh Suntharalingam; Meghan R Perry; Stephen Ward; Stephen J Brett; Andrew Castello-Cortes; Michael D Brunner; Nicki Panoskaltsis Journal: N Engl J Med Date: 2006-08-14 Impact factor: 91.245
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Authors: Martin H Bernardi; Harald Rinoesl; Klaus Dragosits; Robin Ristl; Friedrich Hoffelner; Philipp Opfermann; Christian Lamm; Falk Preißing; Dominik Wiedemann; Michael J Hiesmayr; Andreas Spittler Journal: Crit Care Date: 2016-04-09 Impact factor: 9.097