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Review
. 2019 Nov;114(8):699-707.
doi: 10.1007/s00063-017-0342-5. Epub 2017 Sep 4.

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

S Friesecke  1 , K Träger  2 , G A Schittek  3 , Z Molnar  4 , F Bach  5 , K Kogelmann  6 , R Bogdanski  7 , A Weyland  8 , A Nierhaus  9 , F Nestler  10 , D Olboeter  11 , D Tomescu  12 , D Jacob  13 , H Haake  14 , E Grigoryev  15 , M Nitsch  16 , A Baumann  17 , M Quintel  18 , M Schott  19 , J T Kielstein  20 , A Meier-Hellmann  21 , F Born  22 , U Schumacher  23 , M Singer  24 , J Kellum  25 , F M Brunkhorst  26   27   28
Affiliations
Review

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

S Friesecke et al. Med Klin Intensivmed Notfmed. 2019 Nov.

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.

Keywords: Cytokines; Extracorporeal life support; Inflammation; Intensive care units; Sepsis.

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