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Completed

NCT Number: NCT02312024

International Registry on the Use of the CytoSorb Adsorber

Registry on the use of the CytoSorb® adsorber in ICU patients.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Krankenhaus Hietzing, Vienna, Austria

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • none

Treatment and study plan

Use of CytoSorb adsorber

Device

Use of CytoSorb adsorber either in patients with severe sepsis/septic shock or with cardiac surgery with CPB or in other patients.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Jena University Hospital

Other

Collaborators

  • University Hospital Goettingen

Registry information

Official study title

International Registry on the Use of the CytoSorb®-Adsorber in ICU Patients

Acronym: CytoSorb

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Dec 9, 2014
Registry last updated
Oct 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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