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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02312024
Recruitment Status : Unknown
Verified December 2019 by Jena University Hospital.
Recruitment status was:  Recruiting
First Posted : December 9, 2014
Last Update Posted : December 16, 2019
Sponsor:
Collaborator:
University Hospital Goettingen
Information provided by (Responsible Party):
Jena University Hospital

Study Description
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Brief Summary:
Registry on the use of the CytoSorb® adsorber in ICU patients.

Condition or disease Intervention/treatment
Sepsis Need of Cardiac Surgery Device: Use of CytoSorb adsorber

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 Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 3000 participants
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
Study Start Date : January 2015
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Groups and Cohorts
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Group/Cohort Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. - Organ function (SOFA - score-difference) [ Time Frame: days ]
  2. - Concentration of biomarkers IL-6, CRP, PCT, myoglobin, free hemoglobin [ Time Frame: days ]
  3. - Length of hospital and ICU stay (days) [ Time Frame: days ]
  4. - Duration of mechanical ventilation (days) [ Time Frame: days ]
  5. - Duration of renal replacement therapy (days) [ Time Frame: days ]
  6. - Duration of vasopressor therapy (days) [ Time Frame: days ]

Eligibility Criteria
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Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02312024


Contacts
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Contact: Frank M. Brunkhorst, Prof. +49 3641 9 3966 ext 87 frank.brunkhorst@med.uni-jena.de
Contact: Manja Schein +49 3641 9 39 66 ext 93 manja.schein@med.uni-jena.de

Locations
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Sponsors and Collaborators
Jena University Hospital
University Hospital Goettingen
Investigators
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Principal Investigator: Frank M. Brunkhorst, Prof. Center for Clinical Studies at Jena University Hospital
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jena University Hospital
ClinicalTrials.gov Identifier: NCT02312024    
Other Study ID Numbers: JenaUH
First Posted: December 9, 2014    Key Record Dates
Last Update Posted: December 16, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jena University Hospital:
CytoSorb adsorber
sepsis
cytokines
 hemofiltration
hemadsorption
inflammation
Additional relevant MeSH terms:
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Sepsis
Infections
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes