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

This study is currently recruiting participants.
Verified June 2016 by Jena University Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT02312024
First Posted: December 9, 2014
Last Update Posted: June 6, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
University Hospital Goettingen
Information provided by (Responsible Party):
Jena University Hospital
December 4, 2014
December 9, 2014
June 6, 2016
January 2015
December 2017   (Final data collection date for primary outcome measure)
Difference between mortality predicted by scoring systems (APACHE II/SAPS II, EuroSCORE II) and actual mortality within 30 days after intervention [ Time Frame: days ]
Difference between mortality predicted by scoring systems (APACHE II/SAPS II, EuroSCORE II) and actual mortality within 30 days after intervention [ Time Frame: 30 days ]
Complete list of historical versions of study NCT02312024 on ClinicalTrials.gov Archive Site
  • - 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 ]
  • - Organ function (SOFA - score-difference) [ Time Frame: 30 days ]
  • - Concentration of biomarkers IL-6, CRP, PCT, myoglobin, free hemoglobin [ Time Frame: 30 days ]
  • - Length of hospital and ICU stay (days) [ Time Frame: 30 days ]
  • - Duration of mechanical ventilation (days) [ Time Frame: 30 days ]
  • - Duration of renal replacement therapy (days) [ Time Frame: 30 days ]
  • - Duration of vasopressor therapy (days) [ Time Frame: 30 days ]
Not Provided
Not Provided
 
International Registry on the Use of the CytoSorb Adsorber
International Registry on the Use of the CytoSorb®-Adsorber in ICU Patients
Registry on the use of the CytoSorb® adsorber in ICU patients.

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.

Observational [Patient Registry]
Observational Model: Case-Only
Time Perspective: Prospective
30 Days
Not Provided
Non-Probability Sample
Patients undergoing treatment with the CytoSorb® adsorber
  • Sepsis
  • Need of Cardiac Surgery
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.
  • Patients with severe sepsis/septic shock
    Use of CytoSorb adsorber in patients with severe sepsis/septic shock
    Intervention: Device: Use of CytoSorb adsorber
  • 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
    Intervention: Device: Use of CytoSorb adsorber
Not Provided
 
Recruiting
3000
December 2020
December 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

- none

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
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
Austria,   Germany,   Hungary
 
 
NCT02312024
JenaUH
No
Not Provided
Not Provided
Jena University Hospital
Jena University Hospital
University Hospital Goettingen
Principal Investigator: Frank M. Brunkhorst, Prof. Center for Clinical Studies at Jena University Hospital
Jena University Hospital
June 2016