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International registry on the use of the CytoSorb® adsorber in ICU patients

Study protocol and preliminary results

Internationales Register zur Nutzung des Adsorbers CytoSorb® bei Intensivpatienten

Studienprotokoll und erste Ergebnisse

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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.

Zusammenfassung

Einleitung

Zweck des vorgestellten klinischen Registers ist es, die Nutzung des Adsorbers CytoSorb® bei kritisch kranken Patienten unter Realbedingungen zu erfassen.

Methoden

Dokumentiert werden Diagnose, Komorbiditäten, Verlauf der Erkrankung, Behandlung, Begleitmedikation und Laborparameter (ClinicalTrials.gov-Identifier: NCT02312024). Primärer Endpunkt ist die Krankenhausmortalität im Vergleich zur Mortalität, die mit dem APACHE-II- bzw. SAPS-II-Score prognostiziert wurde.

Ergebnisse

Mit Stand vom 30. Januar 2017 nahmen 130 Zentren aus 22 Ländern am Register teil. Verfügbare Daten vom 18. Mai 2015 bis 24. November 2016 (122 Zentren; 22 Länder) wurden analysiert. Zwanzig dieser Zentren aus 4 Ländern lieferten Daten zu insgesamt 198 Patienten (Alter 60,3 ± 15,1 Jahre, 135 Männer [68,2 %]). Insgesamt 192 (97,0 %) hatten 1–5 Cytosorb®-Adsorber-Anwendungen. Sepsis war die häufigste Indikation zur CytoSorb®-Behandlung (135 Patienten). Der durchschnittliche APACHE-II-Score in dieser Gruppe betrug 33,1 ± 8,4 mit einem prognostizierten Sterberisiko von 78 %, während die beobachtete Mortalität bei 65 % lag. Es fanden sich keine signifikanten Verringerungen in den SOFA-Scores nach Behandlung (17,2 ± 4,8 [3–24]). Die Interleukin-6-Spiegel waren allerdings nach Behandlung deutlich reduziert (im Median 5000 pg/ml vor und 289 pg/ml nach Behandlung).

Schlussfolgerungen

Dieser dritte Zwischenbericht belegt die Machbarkeit des Registers mit einer exzellenten Datenqualität und -vollständigkeit aus 20 Studienzentren. Die Ergebnisse sind mit Zurückhaltung zu interpretieren, da die Patientenzahl immer noch gering ist; die Erkrankungsschwere ist allerdings bemerkenswert hoch, was vermuten lässt, dass der Adsorber als Ultima Ratio genutzt wird. Es gab keine device-assoziierten Nebenwirkungen.

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Funding

Supported with unrestricted grants by CytoSorbents Europe GmbH

Author information

Authors and Affiliations

  1. Klinik und Poliklinik für Innere Medizin B, Universitätsmedizin Greifswald, Greifswald, Germany

    S. Friesecke

  2. Kardioanästhesiologie, Universitätsklinikum Ulm, Ulm, Germany

    K. Träger

  3. Klinik für Anästhesiologie, Intensivtherapie und Palliativmedizin, Carl-Thiem-Klinikum Cottbus, Cottbus, Germany

    G. A. Schittek

  4. Department of Anesthesiology and Intensive Care, University of Szeged, Szeged, Hungary

    Z. Molnar

  5. Klinik für Anästhesiologie, Intensiv‑, Notfallmedizin, Transfusionsmedizin und Schmerztherapie, Evangelisches Krankenhaus Bielefeld, Bielefeld, Germany

    F. Bach

  6. Klinik für Anästhesiologie und Intensivmedizin, Hans-Susemihl-Krankenhaus gGmbH, Emden, Germany

    K. Kogelmann

  7. Klinik für Anästhesiologie, AG Hämodynamik, Klinikum rechts der Isar TU München, München, Germany

    R. Bogdanski

  8. Universitätsklinik für Anästhesiologie/Intensiv‑/Notfallmedizin/Schmerztherapie, Klinikum Oldenburg gGmbH, Carl von Ossietzky Universität, Oldenburg, Germany

    A. Weyland

  9. Klinik für Intensivmedizin, Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany

    A. Nierhaus

  10. Anästhesie und Intensivmedizin, Kliniken Erlabrunn gGmbH, Breitenbrunn, Germany

    F. Nestler

  11. Anästhesie und Intensivmedizin, Krankenhaus Herzberg, Elbe-Elster-Klinikum GmbH, Herzberg, Germany

    D. Olboeter

  12. Fundeni Clinical Institute, Bucharest, Romania

    D. Tomescu

  13. Klinik für Allgemein‑, Viszeral- und Gefäßchirurgie, Universitätsklinikum Magdeburg, Magdeburg, Germany

    D. Jacob

  14. Klinik für Kardiologie und Intensivmedizin, Kliniken Maria Hilf GmbH, Mönchengladbach, Germany

    H. Haake

  15. Institute for Complex Issues of Cardiovascular Diseases, Kemerovo, Russian Federation

    E. Grigoryev

  16. Klinik für Anästhesie, Intensiv‑, Notfallmedizin und Schmerztherapie, Krankenhaus St. Elisabeth und St. Barbara Halle, Halle, Germany

    M. Nitsch

  17. Klinik für Anästhesie, Intensiv‑, Palliativ- und Schmerzmedizin, Berufsgenossensch. Uniklinik Bergmannsheil, Bochum, Germany

    A. Baumann

  18. Zentrum Anästhesiologie, Rettungs-und Intensivmedizin, Universitätsklinikum Göttingen, Göttingen, Germany

    M. Quintel

  19. Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie, Klinikum Region Hannover Nordstadt, Hannover, Germany

    M. Schott

  20. Medizinische Klinik V, Klinikum Braunschweig, Braunschweig, Germany

    J. T. Kielstein

  21. Anästhesie, Intensivmedizin und Schmerztherapie, HELIOS Klinikums Erfurt, Erfurt, Germany

    A. Meier-Hellmann

  22. Herzchirurgische Klinik und Poliklinik, LMU München, München, Germany

    F. Born

  23. Center for Clinical Studies Jena (ZKS), Jena, Germany

    U. Schumacher &  F. M. Brunkhorst

  24. Intensive Care Medicine, University College London, London, UK

    M. Singer

  25. Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, USA

    J. Kellum

  26. Center for Sepsis Control and Care (CSCC), Jena, Germany

    F. M. Brunkhorst

  27. Department of Anaesthesiology and Intensive Care Medicine, Jena University Hospital, Erlanger Allee 101, 07747, Jena, Germany

    F. M. Brunkhorst

Authors
  1. S. Friesecke
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  2. K. Träger
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  3. G. A. Schittek
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  4. Z. Molnar
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  5. F. Bach
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  8. A. Weyland
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  9. A. Nierhaus
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  10. F. Nestler
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  11. D. Olboeter
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  13. D. Jacob
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  23. U. Schumacher
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  24. M. Singer
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  25. J. Kellum
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  26. F. M. Brunkhorst
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Corresponding author

Correspondence to F. M. Brunkhorst.

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Conflict of interest

F. Bach, R. Bogdanski, F. Born, E. Grigoryev, H. Haake, D. Jacob, J.T. Kielstein, A. Meier-Hellmann, F. Nestler, M. Nitsch, D. Olboeter, M. Schott, M. Singer and D. Tomescu declare that they have no competing interests. A. Baumann reports grants, personal fees and nonfinancial support from Cytosorbents GmbH, personal fees and nonfinancial support from Diamed GmbH, nonfinancial support and other from Orion Pharma, nonfinancial support and other from MSD Pharma, outside the submitted work. F.M. Brunkhorst reports grants and personal fees from CytoSorbents Europe. S. Friesecke reports grants, personal fees and nonfinancial support from cytosorbents Europe. J. Kellum reports grants and personal fees from Cytostorbenets, outside the submitted work. K. Kogelmann reports grants from Cytostorbenets, outside the submitted work. Z. Molnar reports personal fees from CytoSorbents Europe. A. Nierhaus reports personal fees from CytoSorbents Europe, Personal fees from Biotest AG, outside the submitted work. M. Quintel reports personal fees from Cytosorbent, outside the submitted work. G.A. Schittek reports personal fees from Cytosorbents Europe GmbH, outside the submitted work. U. Schumacher reports personal fees from BAYER, outside the submitted work (part time employee). K. Träger reports personal fees and other from Cytosorbents Europe. A. Weyland reports personal fees and other from CytoSorbents Europe GmbH, outside the submitted work.

This study protocol has been submitted to the Institutional Review Board of the Faculty of Medicine at Friedrich Schiller University, Jena that acts as the IRB in charge for Germany. All German ethic committees involved are informed about the participation of centers in their area of responsibility and the decision of the IRB in charge. In centers from outside Germany, approval of the local ethics commission in charge is obtained and all national regulations are adhered to.

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63_2017_342_MOESM1_ESM.pdf

1. Flowcharts and data content in the eCRF, 2. Severity scores, 3. Criteria defining sepsis and septic shock, 4. Abbreviations

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Friesecke, S., Träger, K., Schittek, G.A. et al. International registry on the use of the CytoSorb® adsorber in ICU patients. Med Klin Intensivmed Notfmed 114, 699–707 (2019). https://doi.org/10.1007/s00063-017-0342-5

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