International Registry on the Use of the CytoSorb Adsorber

Completed

• Conditions: Sepsis; Need of Cardiac Surgery
• Interventions: Device: Use of CytoSorb adsorber

• Registration Number: NCT02312024
• Lead Sponsor: Jena University Hospital

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.

Study Timeline

• Study First Submitted: 2014-12-04
• Study First Submitted QC: 2014-12-04
• Study First Posted: 2014-12-09
• Study Start: 2015-01
• Status Verified: 2019-12
• Primary Completion: 2021-02-04
• Study Completion: 2021-02-04
• Last Update Submitted: 2024-10-21
• Last Update Posted: 2024-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1434

Inclusion Criteria

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

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with other indications	Use of CytoSorb adsorber	Use of CytoSorb adsorber in patients with other indications
Patients with severe sepsis/septic shock	Use of CytoSorb adsorber	Use of CytoSorb adsorber in patients with severe sepsis/septic shock

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (19)

Krankenhaus Hietzing; 🇦🇹 Wien, 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, Germany

Greifswald University Hospital; 🇩🇪 Greifswald, Germany

Universitätsmedizin Göttingen; 🇩🇪 Göttingen, 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