Clinical trial NCT02312024: International Registry on the Use of the CytoSorb Adsorber
Official title: International Registry on the Use of the CytoSorb®-Adsorber in ICU Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Need of Cardiac Surgery
Keywords: CytoSorb adsorber
sepsis
cytokines
hemofiltration
hemadsorption
inflammation
Lead sponsor: Jena University Hospital
Sponsor class: OTHER
Collaborators: name: University Hospital Goettingen
First posted: 2014-12-09
Enrollment: 1434
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing treatment with the CytoSorb® adsorber

Brief summary: Registry on the use of the CytoSorb® adsorber in ICU patients.

Detailed description: The aim of this registry is to record the use of CytoSorb® under real life conditions in as many cases as possible (preferably all or, at least, in a representative sample). All CytoSorb® applications in different clinical settings and in all patients who are treated with this technology in Germany, Austria and Switzerland (target population) are planned to be included.

The objectives of the registry are collection of real-life data on a broad scale, their centralized, structured and comprehensive documentation, and a controlled data exchange. The gathered information will be used to augment the knowledge on the clinical efficacy of the technology, to optimize the quality of its therapeutic application, and to identify and promptly handle possible complications related to the use of CytoSorb®. The registry will record all relevant information in the course of product use, e.g. diagnosis, comorbidities, course of the condition, treatment, concomitant medication and clinical laboratory parameters.

The registry will inform physicians of different medical specialties about the range of possible applications of CytoSorb® and invite them to contribute their own experiences to the registry. This is done by giving them access to their own data and to the results of periodic analyses (for contributing participants), and via publications of the results (for participants and external interested parties)

The CytoSorb® registry will provide the data base for justified and optimized decisions. An active form of data collection where data is prospectively collected by qualified staff is particularly suited for this purpose.

Registry data might help closing knowledge gaps and open practical issues. Due to the patient group's heterogeneity, the registry can identify sub-groups, assess their risk-benefit-profile and examine their safety profile. Registry data are absolutely essential for assessing a therapy's significance within the healthcare landscape.

Institutions that contribute data to the registry benefit in several ways: They will obtain a continuous retrospective feedback of their own results, their data will be periodically compared with data from other participating sites, and they will get access to regularly published analyses of the results of all participants. On the basis of these data, they can establish a quality monitoring and optimize their use of CytoSorb®.

The planned endpoints allow for a comprehensive description of CytoSorb® efficacy in terms of several indication-relevant aspects. Together with the monitoring of application safety, these data build the basis for establishing benchmarks that promote a higher treatment quality.

Eligibility criteria: Inclusion Criteria:

* Use of the CytoSorb® adsorber
* Age ≥ 18 years
* Signed informed consent

Exclusion Criteria:

- none

Primary outcomes:
measure: Difference between mortality predicted by scoring systems (APACHE II/SAPS II, EuroSCORE II) and actual mortality within 30 days after intervention
timeFrame: days
Secondary outcomes:
measure: - Organ function (SOFA - score-difference)
timeFrame: days
measure: - Concentration of biomarkers IL-6, CRP, PCT, myoglobin, free hemoglobin
timeFrame: days
measure: - Length of hospital and ICU stay (days)
timeFrame: days
measure: - Duration of mechanical ventilation (days)
timeFrame: days
measure: - Duration of renal replacement therapy (days)
timeFrame: days
measure: - Duration of vasopressor therapy (days)
timeFrame: days
Other outcomes:
Locations:
city: Wien
country: Austria
facility: Krankenhaus Hietzing
city: Berlin
country: Germany
facility: Vivantes Klinikum Neukölln
city: Bielefeld
country: Germany
facility: Evangelisches Krankenhaus
city: Cottbus
country: Germany
facility: Carl-Thiem-Klinikum
city: Düsseldorf
country: Germany
facility: Universitätsklinikum Düsseldorf
city: Emden
country: Germany
facility: Klinikum Emden
city: Erlabrunn
country: Germany
facility: Kliniken Erlabrunn gGmbH
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg
city: Greifswald
country: Germany
facility: Greifswald University Hospital
city: Göttingen
country: Germany
facility: Universitätsmedizin Göttingen
city: Halle
country: Germany
facility: Krankenhaus St. Elisabeth & St. Barbara
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
city: Herzberg
country: Germany
facility: Krankenhaus Herzberg, Elbe-Elster-Klinikum GmbH
city: Mönchengladbach
country: Germany
facility: Kliniken Maria Hilf GmbH Mönchengladbach
city: München
country: Germany
facility: Klinikum rechts der Isar der TU München
city: Oldenburg
country: Germany
facility: Klinikum Oldenburg
city: Ulm
country: Germany
facility: University Hospital Ulm
city: Weiden
country: Germany
facility: Kliniken Nordoberpfalz AG, Klinikum Weiden
city: Szeged
country: Hungary
facility: University of Szeged
Study officials:
affiliation: Center for Clinical Studies at Jena University Hospital
name: Frank M. Brunkhorst, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hawchar F, Tomescu D, Trager K, Joskowiak D, Kogelmann K, Soukup J, Friesecke S, Jacob D, Gummert J, Faltlhauser A, Aucella F, van Tellingen M, Malbrain MLNG, Bogdanski R, Weiss G, Herbrich A, Utzolino S, Nierhaus A, Baumann A, Hartjes A, Henzler D, Grigoryev E, Fritz H, Bach F, Schroder S, Weyland A, Gottschaldt U, Menzel M, Zachariae O, Novak R, Berden J, Haake H, Quintel M, Kloesel S, Kortgen A, Stecher S, Torti P, Nestler F, Nitsch M, Olboeter D, Muck P, Findeisen M, Bitzinger D, Krassler J, Benad M, Schott M, Schumacher U, Molnar Z, Brunkhorst FM. Hemoadsorption in the critically ill-Final results of the International CytoSorb Registry. PLoS One. 2022 Oct 25;17(10):e0274315. doi: 10.1371/journal.pone.0274315. eCollection 2022.
citation: Schittek GA, Zoidl P, Eichinger M, Orlob S, Simonis H, Rief M, Metnitz P, Fellinger T, Soukup J. Adsorption therapy in critically ill with septic shock and acute kidney injury: a retrospective and prospective cohort study. Ann Intensive Care. 2020 Nov 18;10(1):154. doi: 10.1186/s13613-020-00772-7.
citation: Friesecke S, Trager K, Schittek GA, 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 JT, Meier-Hellmann A, Born F, Schumacher U, Singer M, Kellum J, Brunkhorst FM. International registry on the use of the CytoSorb(R) adsorber in ICU patients : Study protocol and preliminary results. Med Klin Intensivmed Notfmed. 2019 Nov;114(8):699-707. doi: 10.1007/s00063-017-0342-5. Epub 2017 Sep 4.