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International registry on the use of the CytoSorb® adsorber in ICU patients: Study protocol and preliminary results

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, treatm...

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Published in:Medizinische Klinik, Intensivmedizin und Notfallmedizin Intensivmedizin und Notfallmedizin, 2019-11, Vol.114 (8), p.699-707
Main Authors: Friesecke, S., Träger, K., Schittek, G. A., Molnar, Z., Bach, F., Kogelmann, K., Bogdanski, R., Weyland, A., Nierhaus, A., Nestler, F., Olboeter, D., Tomescu, D., Jacob, D., Haake, H., Grigoryev, E., Nitsch, M., Baumann, A., Quintel, M., Schott, M., Kielstein, J. T., Meier-Hellmann, A., Born, F., Schumacher, U., Singer, M., Kellum, J., Brunkhorst, F. M.
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container_title Medizinische Klinik, Intensivmedizin und Notfallmedizin
container_volume 114
creator Friesecke, S.
Träger, K.
Schittek, G. A.
Molnar, Z.
Bach, F.
Kogelmann, K.
Bogdanski, R.
Weyland, A.
Nierhaus, A.
Nestler, F.
Olboeter, D.
Tomescu, D.
Jacob, D.
Haake, H.
Grigoryev, E.
Nitsch, M.
Baumann, A.
Quintel, M.
Schott, M.
Kielstein, J. T.
Meier-Hellmann, A.
Born, F.
Schumacher, U.
Singer, M.
Kellum, J.
Brunkhorst, F. M.
description 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.
doi_str_mv 10.1007/s00063-017-0342-5
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A. ; Molnar, Z. ; Bach, F. ; Kogelmann, K. ; Bogdanski, R. ; Weyland, A. ; Nierhaus, A. ; Nestler, F. ; Olboeter, D. ; Tomescu, D. ; Jacob, D. ; Haake, H. ; Grigoryev, E. ; Nitsch, M. ; Baumann, A. ; Quintel, M. ; Schott, M. ; Kielstein, J. T. ; Meier-Hellmann, A. ; Born, F. ; Schumacher, U. ; Singer, M. ; Kellum, J. ; Brunkhorst, F. M.</creator><creatorcontrib>Friesecke, S. ; Träger, K. ; Schittek, G. A. ; Molnar, Z. ; Bach, F. ; Kogelmann, K. ; Bogdanski, R. ; Weyland, A. ; Nierhaus, A. ; Nestler, F. ; Olboeter, D. ; Tomescu, D. ; Jacob, D. ; Haake, H. ; Grigoryev, E. ; Nitsch, M. ; Baumann, A. ; Quintel, M. ; Schott, M. ; Kielstein, J. T. ; Meier-Hellmann, A. ; Born, F. ; Schumacher, U. ; Singer, M. ; Kellum, J. ; Brunkhorst, F. M.</creatorcontrib><description>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. 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T.</creatorcontrib><creatorcontrib>Meier-Hellmann, A.</creatorcontrib><creatorcontrib>Born, F.</creatorcontrib><creatorcontrib>Schumacher, U.</creatorcontrib><creatorcontrib>Singer, M.</creatorcontrib><creatorcontrib>Kellum, J.</creatorcontrib><creatorcontrib>Brunkhorst, F. M.</creatorcontrib><title>International registry on the use of the CytoSorb® adsorber in ICU patients: Study protocol and preliminary results</title><title>Medizinische Klinik, Intensivmedizin und Notfallmedizin</title><addtitle>Med Klin Intensivmed Notfmed</addtitle><addtitle>Med Klin Intensivmed Notfmed</addtitle><description>Introduction The aim of this clinical registry is to record the use of CytoSorb® adsorber device in critically ill patients under real-life conditions. 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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. 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T.</au><au>Meier-Hellmann, A.</au><au>Born, F.</au><au>Schumacher, U.</au><au>Singer, M.</au><au>Kellum, J.</au><au>Brunkhorst, F. M.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>International registry on the use of the CytoSorb® adsorber in ICU patients: Study protocol and preliminary results</atitle><jtitle>Medizinische Klinik, Intensivmedizin und Notfallmedizin</jtitle><stitle>Med Klin Intensivmed Notfmed</stitle><addtitle>Med Klin Intensivmed Notfmed</addtitle><date>2019-11-01</date><risdate>2019</risdate><volume>114</volume><issue>8</issue><spage>699</spage><epage>707</epage><pages>699-707</pages><issn>2193-6218</issn><eissn>2193-6226</eissn><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. 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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.</abstract><cop>Heidelberg</cop><pub>Springer Medizin</pub><pmid>28871441</pmid><doi>10.1007/s00063-017-0342-5</doi><tpages>9</tpages></addata></record>
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subjects Critical Care Medicine
Emergency Medicine
Intensive
Internal Medicine
Medicine
Medicine & Public Health
Übersichten
title International registry on the use of the CytoSorb® adsorber in ICU patients: Study protocol and preliminary results
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