ClinicalTrials.gov record NCT05146336
CytOSorb TreatMent Of Critically Ill PatientS Registry
CytOSorb TreatMent Of Critically Ill PatientS Registry: International Registry on the Use of CytoSorb in the Critical Care Setting
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
A prospective registry collecting data on critically ill patients treated with the CytoSorb hemoperfusion device. It creates a central repository for surveillance and reporting of real-world device use in critical care. The registry records outcomes including ICU and in-hospital mortality.
What it is studying. Whether and how CytoSorb is used in routine critical-care practice and how patient outcomes and safety events relate to that use.
What the researchers hope to learn. To build a data repository and reporting infrastructure for surveillance of CytoSorb use in real-world critical care; to describe usage patterns, safety signals, and outcomes such as ICU and in-hospital mortality.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
Registry intended to provide a data repository and reporting infrastructure for the surveillance of CytoSorb device use in real-world critical care settings, and to serve as an objective, comprehensive, and scientifically-based resource to measure and improve the quality of patient care
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Device
- CytoSorb
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- Planned OR actual CytoSorb® 300 mL device utilization
- Informed consent for prospective registry participation
Exclusion criteria
- Use of the CytoSorb® 300 mL device for antithrombotic removal only
- Intraoperative use of CytoSorb® 300 mL device during cardiac surgery only
- The occurrence of a complication or other medically justified circumstance that arises after written informed consent has been obtained from the patient and before or during the planned therapy and as a result of which the use of CytoSorb® 300 mL Adsorber is contraindicated or no longer appropriate.
Study description and what participation involves
The registry record has no detailed description beyond the summary above.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
After giving informed consent, participants who have planned or received CytoSorb® 300 mL treatment will have information about their CytoSorb use and clinical course entered into the registry. The registry records outcomes such as ICU mortality (through ICU discharge) and in-hospital mortality (through hospital discharge) and follows participants until those discharge points. The registry record does not specify other study procedures, extra visits, biological sample collection, or participant services.
How the study is structured. A prospective observational registry: patients who receive CytoSorb as part of usual care are entered into a cohort and followed; the study collects clinical information and outcomes but does not assign any experimental treatment.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
- The listed sites are in Austria, Germany, Italy, Poland, Portugal, Spain. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
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Important dates
- Study start
- Jun 22, 2022
- Primary completion
- June 2032 (estimated)
- Study completion
- September 2032 (estimated)
- Target enrollment
- 3000 participants (estimated)
- Last updated on registry
- Sep 11, 2025
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- CytoSorbents, Inc
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Robert Wilke 📞 +49 30 654 99 145 ✉ cosmos@cytosorbents.com
Participating sites (28)
- Klinikum Klagenfurt am WörtherseeRecruiting
Klagenfurt, 9020 · Austria
- Markus Köstenberger, Dr.
- Medizinische Universität WienRecruiting
Vienna, 1090 · Austria
- Martin Bernardi, ap. Prof. Priv.-Doz. Dr. Dr.
- Universitätsklinikum AachenRecruiting
Aachen, 52074 · Germany
- Philipp Hohlstein, MD
- Herz- und Diabeteszentrum Nordrhein-WestfalenRecruiting
Bad Oeynhausen, 32545 · Germany
- Thomas Kirschning, MD
- Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil BochumRecruiting
Bochum, 44789 · Germany
- Nathalie Malewicz-Oeck, MD
- Katholisches Klinikum Bochum, St. Josef-HospitalRecruiting
Bochum, 44791 · Germany
- Martin Bellgardt, MD, PD
- Universitätsklinikum Essen, Medizinische IntensivtherapieRecruiting
Essen, 45147 · Germany
- Bartosz Tyczynski, MD
- Universitätsklinikum Essen, NephrologieRecruiting
Essen, 45147 · Germany
- Kristin Schönfelder, MD
- Universitätsklinikum Essen, Thorax- und Kardiovaskuläre ChirurgieRecruiting
Essen, 45147 · Germany
- Matthias Thielmann, MD, Prof
- Universitätsmedizin Göttingen, Allgemein-, Viszeral- und KinderchirurgieRecruiting
Göttingen, 37075 · Germany
- Thorsten Perl, MD, PD
Terms used on this page · explanations by MedicalUpdates.ai
- Registry
- An organised collection of information about people with a particular condition, gathered over time for research. Joining a registry usually means sharing medical information, not receiving a treatment.
- Informed consent
- The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
- contraindicated
- A reason a particular test or treatment should not be used for a person, for example a metal implant that rules out an MRI scan.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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