International Registry on the Use of the CytoSorb Adsorber

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

Detailed Description
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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.

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

Conditions
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Sepsis, Need of Cardiac Surgery

Intervention / Treatment
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* Device: Use of CytoSorb adsorber


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Use of the CytoSorb® adsorber Age ≥ 18 years Signed informed consent Exclusion Criteria: - none

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with severe sepsis/septic shock<br>Use of CytoSorb adsorber in patients with severe sepsis/septic shock | Device: Use of CytoSorb adsorber<br>* Use of CytoSorb adsorber either in patients with severe sepsis/septic shock or with cardiac surgery with CPB or in other patients.<br>|
| Cardiac surgery with CPB: preemptive use<br>Use of CytoSorb adsorber in patients with cardiac surgery with CPB: preemptive use | |
| Cardiac surgery with CPB: postop. use<br>Use of CytoSorb adsorber in patients with cardiac surgery with CPB: postoperative use | |
| Patients with other indications<br>Use of CytoSorb adsorber in patients with other indications | Device: Use of CytoSorb adsorber<br>* Use of CytoSorb adsorber either in patients with severe sepsis/septic shock or with cardiac surgery with CPB or in other patients.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference between mortality predicted by scoring systems (APACHE II/SAPS II, EuroSCORE II) and actual mortality within 30 days after intervention |  | days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - Organ function (SOFA - score-difference) |  | days | 
| - Concentration of biomarkers IL-6, CRP, PCT, myoglobin, free hemoglobin |  | days | 
| - Length of hospital and ICU stay (days) |  | days | 
| - Duration of mechanical ventilation (days) |  | days | 
| - Duration of renal replacement therapy (days) |  | days | 
| - Duration of vasopressor therapy (days) |  | days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CytoSorb adsorber, sepsis, cytokines, hemofiltration, hemadsorption, inflammation