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

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ClinicalTrials.gov Identifier: NCT02312024
Recruitment Status : Recruiting
First Posted : December 9, 2014
Last Update Posted : May 30, 2018
Sponsor:
Collaborator:
University Hospital Goettingen
Information provided by (Responsible Party):
Jena University Hospital

Tracking Information
First Submitted Date December 4, 2014
First Posted Date December 9, 2014
Last Update Posted Date May 30, 2018
Study Start Date January 2015
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 21, 2015)
Difference between mortality predicted by scoring systems (APACHE II/SAPS II, EuroSCORE II) and actual mortality within 30 days after intervention [ Time Frame: days ]
Original Primary Outcome Measures
 (submitted: December 4, 2014)
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 ]
Change History Complete list of historical versions of study NCT02312024 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: August 21, 2015)
  • - 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 ]
Original Secondary Outcome Measures
 (submitted: December 4, 2014)
  • - 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title International Registry on the Use of the CytoSorb Adsorber
Official Title International Registry on the Use of the CytoSorb®-Adsorber in ICU Patients
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 Type Observational [Patient Registry]
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration 30 Days
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients undergoing treatment with the CytoSorb® adsorber
Condition
  • Sepsis
  • Need of Cardiac Surgery
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.
Study Groups/Cohorts
  • 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
Publications * Friesecke S, Träger K, Schittek GA, Molnar Z, Bach F, Kogelmann K, Bogdanski R, Weyland A, Nierhaus A, Nestler F, Olboeter D, Tomescu D, Jacob D, Haake H, Grigoryev E, Nitsch M, Baumann A, Quintel M, Schott M, Kielstein JT, Meier-Hellmann A, Born F, Schumacher U, Singer M, Kellum J, Brunkhorst FM. International registry on the use of the CytoSorb® adsorber in ICU patients : Study protocol and preliminary results. Med Klin Intensivmed Notfmed. 2017 Sep 4. doi: 10.1007/s00063-017-0342-5. [Epub ahead of print] Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: December 4, 2014)
3000
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

- none

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
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
Listed Location Countries Austria,   Germany,   Hungary
Removed Location Countries  
 
Administrative Information
NCT Number NCT02312024
Other Study ID Numbers JenaUH
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Jena University Hospital
Study Sponsor Jena University Hospital
Collaborators University Hospital Goettingen
Investigators
Principal Investigator: Frank M. Brunkhorst, Prof. Center for Clinical Studies at Jena University Hospital
PRS Account Jena University Hospital
Verification Date May 2018