International Registry on the Use of the CytoSorb Adsorber

Sepsis Clinical Trial

— CytoSorb  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02312024
• Other study ID #: JenaUH
• Status: Recruiting
• Start date: January 2015
• Est. completion date: December 2020

Study information

• Verified date: December 2019
• Source: Jena University Hospital
• Contact: Frank M. Brunkhorst, Prof.
• Phone: +49 3641 9 3966
• Email: frank.brunkhorst[@]med.uni-jena.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Use of the CytoSorb® adsorber

• Age = 18 years

• Signed informed consent

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Need of Cardiac Surgery
• Sepsis

Intervention

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.

Locations

Country	Name	City	State
Austria	Krankenhaus Hietzing	Wien
Germany	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
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
Hungary	University of Szeged	Szeged

Sponsors (2)

Lead Sponsor	Collaborator
Jena University Hospital	University Hospital Goettingen

Countries where clinical trial is conducted

Austria,  Germany,  Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference between mortality predicted by scoring systems (APACHE II/SAPS II, EuroSCORE II) and actual mortality within 30 days after intervention		days
Secondary	- Organ function (SOFA - score-difference)		days
Secondary	- Concentration of biomarkers IL-6, CRP, PCT, myoglobin, free hemoglobin		days
Secondary	- Length of hospital and ICU stay (days)		days
Secondary	- Duration of mechanical ventilation (days)		days
Secondary	- Duration of renal replacement therapy (days)		days
Secondary	- Duration of vasopressor therapy (days)		days

External Links

•   Project website