International Registry on the Use of the CytoSorb Adsorber (CytoSorb)

International Registry on the Use of the CytoSorb®-Adsorber in ICU Patients

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

Study Overview

• Status: Unknown
• Conditions: Sepsis; Need of Cardiac Surgery
• Intervention / Treatment: Device: Use of CytoSorb adsorber

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.

• Study Type: Observational
• Enrollment (Anticipated): 3000

Contacts and Locations

• Study Contact: Name: Frank M. Brunkhorst, Prof.; Phone Number: 87 +49 3641 9 3966; Email: frank.brunkhorst@med.uni-jena.de
• Study Contact Backup: Name: Manja Schein; Phone Number: 93 +49 3641 9 39 66; Email: manja.schein@med.uni-jena.de

Study Locations

• Austria
  • Wien, Austria
    • Recruiting
    • Krankenhaus Hietzing
• Germany
  • Berlin, Germany
    • Not yet recruiting
    • Vivantes Klinikum Neukölln
  • Bielefeld, Germany
    • Recruiting
    • Evangelisches Krankenhaus
  • Cottbus, Germany
    • Recruiting
    • Carl-Thiem-Klinikum
  • Düsseldorf, Germany
    • Not yet recruiting
    • Universitätsklinikum Düsseldorf
  • Emden, Germany
    • Recruiting
    • Klinikum Emden
  • Erlabrunn, Germany
    • Recruiting
    • Kliniken Erlabrunn gGmbH
  • Freiburg, Germany
    • Recruiting
    • Universitätsklinikum Freiburg
  • Greifswald, Germany
    • Recruiting
    • Greifswald University Hospital
  • Göttingen, Germany
    • Recruiting
    • Universitätsmedizin Göttingen
  • Halle, Germany
    • Recruiting
    • Krankenhaus St. Elisabeth & St. Barbara
  • Hamburg, Germany
    • Recruiting
    • Universitätsklinikum Hamburg-Eppendorf
  • Herzberg, Germany
    • Recruiting
    • Krankenhaus Herzberg, Elbe-Elster-Klinikum GmbH
  • Mönchengladbach, Germany
    • Recruiting
    • Kliniken Maria Hilf GmbH Mönchengladbach
  • München, Germany
    • Recruiting
    • Klinikum rechts der Isar der TU Munchen
  • Oldenburg, Germany
    • Recruiting
    • Klinikum Oldenburg
  • Ulm, Germany
    • Recruiting
    • University Hospital Ulm
  • Weiden, Germany
    • Recruiting
    • Kliniken Nordoberpfalz AG, Klinikum Weiden
• Hungary
  • Szeged, Hungary
    • Recruiting
    • University of Szeged

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing treatment with the CytoSorb® adsorber

Description

Inclusion Criteria:

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

Exclusion Criteria:

- none

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with severe sepsis/septic shock; Use of CytoSorb adsorber in patients with severe sepsis/septic shock	Device: Use of CytoSorb adsorber; Use of CytoSorb adsorber either in patients with severe sepsis/septic shock or with cardiac surgery with CPB or in other patients.
Cardiac surgery with CPB: preemptive use; Use of CytoSorb adsorber in patients with cardiac surgery with CPB: preemptive use
Cardiac surgery with CPB: postop. use; Use of CytoSorb adsorber in patients with cardiac surgery with CPB: postoperative use
Patients with other indications; Use of CytoSorb adsorber in patients with other indications	Device: Use of CytoSorb adsorber; Use of CytoSorb adsorber either in patients with severe sepsis/septic shock or with cardiac surgery with CPB or in other patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Difference between mortality predicted by scoring systems (APACHE II/SAPS II, EuroSCORE II) and actual mortality within 30 days after intervention	days

Secondary Outcome Measures

Outcome Measure	Time Frame
- Organ function (SOFA - score-difference)	days
- Concentration of biomarkers IL-6, CRP, PCT, myoglobin, free hemoglobin	days
- Length of hospital and ICU stay (days)	days
- Duration of mechanical ventilation (days)	days
- Duration of renal replacement therapy (days)	days
- Duration of vasopressor therapy (days)	days

Collaborators and Investigators

• Sponsor: Jena University Hospital
• Collaborators: University Hospital Goettingen
• Investigators: Principal Investigator: Frank M. Brunkhorst, Prof., Center for Clinical Studies at Jena University Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Helpful Links

• Project website

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: December 4, 2014
• First Submitted That Met QC Criteria: December 4, 2014
• First Posted (Estimate): December 9, 2014

Study Record Updates

• Last Update Posted (Actual): December 16, 2019
• Last Update Submitted That Met QC Criteria: December 12, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: inflammation; sepsis; cytokines; hemofiltration; CytoSorb adsorber; hemadsorption
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis
• Other Study ID Numbers: JenaUH

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No