Septic ShockCOSMOSNCT05146336
CytOSorb TreatMent Of Critically Ill PatientS Registry
An observational study of Septic Shock and Acute Respiratory Distress Syndrome, run by CytoSorbents, Inc at 28 sites in 6 countries.
Trial summary
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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Septic Shock, Acute Respiratory Distress Syndrome, Trauma
- What is being tested?
- CytoSorb
- Type of treatment
- Medical device
- How many people
- 3,000 participants
- Where
- 28 sitesin 6 countries
- Study dates
- 22 Jun 2022to Sep 2032
- How long will I take part?
- 3 Months
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Critically ill patients receiving CytoSorb therapy
Who may be able to join
- Planned OR actual CytoSorb® 300 mL device utilization
- Informed consent for prospective registry participation
Who cannot join
- 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.
Trial locations and contacts
28 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
28 sites in 6 countries
Germany18 sites, 15 recruiting
- Recruiting
Universitätsklinikum Aachen
Aachen, 52074
Alexander Koch, MD, Prof
- Recruiting
Herz- und Diabeteszentrum Nordrhein-Westfalen
Bad Oeynhausen, 32545
Thomas Kirschning, MD
- Recruiting
Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil Bochum
Bochum, 44789
Nathalie Malewicz-Oeck, MD
- Recruiting
Katholisches Klinikum Bochum, St. Josef-Hospital
Bochum, 44791
Martin Bellgardt, MD, PD
- Recruiting
Universitätsklinikum Essen, Medizinische Intensivtherapie
Essen, 45147
Bartosz Tyczynski, MD
- Recruiting
Universitätsklinikum Essen, Nephrologie
Essen, 45147
Kristin Schönfelder, MD
- Recruiting
Universitätsklinikum Essen, Thorax- und Kardiovaskuläre Chirurgie
Essen, 45147
Matthias Thielmann, MD, Prof
- Recruiting
Universitätsmedizin Göttingen, Allgemein-, Viszeral- und Kinderchirurgie
Göttingen, 37075
Thorsten Perl, MD, PD
- Recruiting
Universitätsmedizin Göttingen, Herzzentrum Göttingen
Göttingen, 37075
Aschraf El-Essawi, MD, PD
- Recruiting
Klinikum Herford
Herford, 32049
Dietrich Henzler, MD, Prof
- Recruiting
Universitätsklinikum Jena
Jena, 07747
Christian Schulze, MD, Prof
- Withdrawn
Klinikum Kassel
Kassel, 34125
- Recruiting
Universitätsklinikum Marburg
Marburg, 35043
Julian Kreutz, MD
- Terminated
Kliniken Maria Hilf
Mönchengladbach, 41063
- Terminated
Deutsches Herzzentrum München
München, 80636
- Recruiting
LMU Klinikum München
München
Christina Scharf-Janßen, MD, PD
- Recruiting
Klinikum Oldenburg
Oldenburg, 26133
Martin Tholl, MD
- Recruiting
Helios Dr. Horst Schmidt Kliniken Wiesbaden
Wiesbaden, 65199
Moritz Unglaube, MD
Austria2 sites, 2 recruiting
- Recruiting
Klinikum Klagenfurt am Wörthersee
Klagenfurt, 9020
Markus Köstenberger, Dr.
- Recruiting
Medizinische Universität Wien
Vienna, 1090
Martin Bernardi, ap. Prof. Priv.-Doz. Dr. Dr.
Italy2 sites, 1 recruiting
- Terminated
Ospedale Pediatrico Bambino Gesù
Roma, 00165
- Recruiting
IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, 71013
Filippo Aucella, MD
Poland2 sites, 2 recruiting
- Recruiting
SP ZOZ Szpital Uniwersytecki w Krakowie
Krakow, 30-688
Anna Wrzosek, Dr.
- Recruiting
Uniwersyteckim Spitalem Klinicznym im. Jana Mikulicza - Radeckiego we Wrocławiu
Wroclaw, 50-556
Waldemar Goździk, Prof
Portugal2 sites, 2 recruiting
- Recruiting
Unidade Local de Saúde de Coimbra E.P.E
Coimbra, 3004-561
Ricardo André Baptista Patrício Silva Freitas, Dr.
- Recruiting
ULS São José, Hospital Curry Cabral
Lisbon
Nuno Germano, MD
Spain2 sites, 2 recruiting
- Recruiting
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona, 08035
Ricard Ferrer Roca, MD
- Recruiting
Hospital Juan Ramón Jimenez
Huelva
Mario Márquez Fernández
About this study
Official title: CytOSorb TreatMent Of Critically Ill PatientS Registry: International Registry on the Use of CytoSorb in the Critical Care Setting
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
- Conditions
- Septic Shock, Acute Respiratory Distress Syndrome, Trauma, Rhabdomyolysis, Cardiogenic Shock, Pancreatitis
- Being tested
- CytoSorb
- Medical subject headings
- Shock, Septic, Respiratory Distress Syndrome, Wounds and Injuries, Rhabdomyolysis, Shock, Cardiogenic, Pancreatitis, Acute-On-Chronic Liver Failure, Liver Failure, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CytoSorbDevice
Sorbent hemoperfusion system
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU mortality
Measured: Through ICU discharge or date of death, whichever comes first [on average 7 days]
In-hospital mortality
Measured: Through hospital discharge or date of death, whichever comes first [on average 14 days]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2021
- Study start22 Jun 2022
- Primary completionJun 2032 (estimated)
- Study completionSep 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- CytoSorbents, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ricard Ferrer Roca, MD, Principal investigator, Hospital Vall d'Hebron
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05146336
- Sponsor's protocol ID
- O06
- Acronym
- COSMOS
- Status last verified
- Oct 2026
- First submitted
- 23 Nov 2021
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ferrer R, Thielmann M, Kribben A, Unglaube M, Tyczynski B, Kreutz J, Baumann A, Guenther U, Henzler D, Kirschning T, El-Essawi A, Gunther T, Bellgardt M, Bottari G, Aucella F, Hidalgo J, Teboul JL, Tomescu D, Klaus T, Fan W, Scheier J, Deliargyris EN, Taccone FS. The international, prospective CytOSorbⓇ treatMent Of critically ill patientS (COSMOS) registry: Interim results from the first 150 patients. J Intensive Med. 2025 Jun 27;5(4):392-399. doi: 10.1016/j.jointm.2025.05.001. eCollection 2025 Oct.
PubMed 41180104Taccone FS, Brunkhorst FM, Bottari G, Hidalgo J, Kribben A, Teboul JL, Tomescu D, Klaus T, Scheier J, Deliargyris E, Ferrer R. The COSMOS Registry of CytoSorb Hemoadsorption Therapy in Critically Ill Patients: Protocol for an International, Prospective Registry. JMIR Res Protoc. 2024 Nov 5;13:e55880. doi: 10.2196/55880.
PubMed 39500494