Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
Trial record 1 of 18 for:    cytosorb
Previous Study | Return to List | Next Study

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2016 by Jena University Hospital
Sponsor:
Collaborator:
University Hospital Goettingen
Information provided by (Responsible Party):
Jena University Hospital
ClinicalTrials.gov Identifier:
NCT02312024
First received: December 4, 2014
Last updated: June 3, 2016
Last verified: June 2016
  Purpose
Registry on the use of the CytoSorb® adsorber in ICU patients.

Condition Intervention
Sepsis
Need of Cardiac Surgery
Device: Use of CytoSorb adsorber

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 30 Days
Official Title: International Registry on the Use of the CytoSorb®-Adsorber in ICU Patients

Resource links provided by NLM:


Further study details as provided by Jena University Hospital:

Primary Outcome Measures:
  • Difference between mortality predicted by scoring systems (APACHE II/SAPS II, EuroSCORE II) and actual mortality within 30 days after intervention [ Time Frame: days ]

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

Estimated Enrollment: 3000
Study Start Date: January 2015
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing treatment with the CytoSorb® adsorber
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

- none

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02312024

Contacts
Contact: Frank M. Brunkhorst, Prof. +49 3641 9 32 33 ext 81 frank.brunkhorst@med.uni-jena.de
Contact: Manja Schein +49 3641 9 39 66 ext 93 manja.schein@med.uni-jena.de

Locations
Austria
Krankenhaus Hietzing Not yet recruiting
Wien, Austria
Germany
Vivantes Klinikum Neukölln Not yet recruiting
Berlin, Germany
Evangelisches Krankenhaus Recruiting
Bielefeld, Germany
Carl-Thiem-Klinikum Recruiting
Cottbus, Germany
Universitätsklinikum Düsseldorf Not yet recruiting
Düsseldorf, Germany
Klinikum Emden Recruiting
Emden, Germany
Kliniken Erlabrunn gGmbH Recruiting
Erlabrunn, Germany
Universitätsklinikum Freiburg Not yet recruiting
Freiburg, Germany
Greifswald University Hospital Recruiting
Greifswald, Germany
Universitätsmedizin Göttingen Not yet recruiting
Göttingen, Germany
Krankenhaus St. Elisabeth & St. Barbara Not yet recruiting
Halle, Germany
Universitätsklinikum Hamburg-Eppendorf Recruiting
Hamburg, Germany
Krankenhaus Herzberg, Elbe-Elster-Klinikum GmbH Recruiting
Herzberg, Germany
Kliniken Maria Hilf GmbH Mönchengladbach Recruiting
Mönchengladbach, Germany
Klinikum rechts der Isar der TU München Recruiting
München, Germany
Krankenhaus Barmherzige Brüder Not yet recruiting
München, Germany
Klinikum Oldenburg Recruiting
Oldenburg, Germany
University Hospital Ulm Recruiting
Ulm, Germany
Kliniken Nordoberpfalz AG, Klinikum Weiden Not yet recruiting
Weiden, Germany
Hungary
University of Szeged Recruiting
Szeged, Hungary
Sponsors and Collaborators
Jena University Hospital
University Hospital Goettingen
Investigators
Principal Investigator: Frank M. Brunkhorst, Prof. Center for Clinical Studies at Jena University Hospital
  More Information

Additional Information:
Responsible Party: Jena University Hospital
ClinicalTrials.gov Identifier: NCT02312024     History of Changes
Other Study ID Numbers: JenaUH
Study First Received: December 4, 2014
Last Updated: June 3, 2016

Keywords provided by Jena University Hospital:
CytoSorb adsorber
sepsis
cytokines
hemofiltration
hemadsorption
inflammation

Additional relevant MeSH terms:
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2017