International Registry on the Use of the CytoSorb Adsorber

NCT ID: NCT02312024

Last Updated: 2024-10-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1434 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2021-02-04

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.

Conditions

Sepsis; Need of Cardiac Surgery

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with severe sepsis/septic shock

Use of CytoSorb adsorber in patients with severe sepsis/septic shock

Use of CytoSorb adsorber

Intervention Type: DEVICE

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

No interventions assigned to this group

Cardiac surgery with CPB: postop. use

Use of CytoSorb adsorber in patients with cardiac surgery with CPB: postoperative use

No interventions assigned to this group

Patients with other indications

Use of CytoSorb adsorber in patients with other indications

Use of CytoSorb adsorber

Intervention Type: DEVICE

Use of CytoSorb adsorber either in patients with severe sepsis/septic shock or with cardiac surgery with CPB or in other patients.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• none

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Goettingen

OTHER

Sponsor Role: collaborator

Jena University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frank M. Brunkhorst, Prof.

Role: PRINCIPAL_INVESTIGATOR

Center for Clinical Studies at Jena University Hospital

Locations

Krankenhaus Hietzing

Vienna, , Austria

Vivantes Klinikum Neukölln

Berlin, , Germany

Evangelisches Krankenhaus

Bielefeld, , Germany

Carl-Thiem-Klinikum

Cottbus, , Germany

Universitätsklinikum Düsseldorf

Düsseldorf, , Germany

Klinikum Emden

Emden, , Germany

Kliniken Erlabrunn gGmbH

Erlabrunn, , Germany

Universitätsklinikum Freiburg

Freiburg im Breisgau, , Germany

Universitätsmedizin Göttingen

Göttingen, , Germany

Greifswald University Hospital

Greifswald, , Germany

Krankenhaus St. Elisabeth & St. Barbara

Halle, , Germany

Universitätsklinikum Hamburg-Eppendorf

Hamburg, , Germany

Krankenhaus Herzberg, Elbe-Elster-Klinikum GmbH

Herzberg, , Germany

Kliniken Maria Hilf GmbH Mönchengladbach

Mönchengladbach, , Germany

Klinikum rechts der Isar der TU München

München, , Germany

Klinikum Oldenburg

Oldenburg, , Germany

University Hospital Ulm

Ulm, , Germany

Kliniken Nordoberpfalz AG, Klinikum Weiden

Weiden, , Germany

University of Szeged

Szeged, , Hungary

Countries

Austria; Germany; Hungary

References

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.

Reference Type: BACKGROUND

PMID: 36282800 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33206229 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28871441 (View on PubMed)

Related Links

http://www.cytosorb-registry.org

Project website

Other Identifiers

JenaUH

Identifier Type: -

Identifier Source: org_study_id