ClinicalTrials.gg
RecruitingNCT05146336COSMOSUpdated Oct 20, 2026

CytOSorb TreatMent Of Critically Ill PatientS Registry

An observational study in Septic Shock, Acute Respiratory Distress Syndrome and Trauma, sponsored by CytoSorbents, Inc. Recruiting at 28 sites in 6 countries. Per ClinicalTrials.gov, last updated 2026-10-20.

Sponsored by CytoSorbents, Inc · Observational

From the registry’s dates

  • Started Jun 2022; still recruiting 4 years 4 months later.
Updated Oct 20, 2026Site recruiting status changedGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
3,000
Sex
All
01

Study 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

02

Conditions studied

  • Septic Shock
  • Acute Respiratory Distress Syndrome
  • Trauma
  • Rhabdomyolysis
  • Cardiogenic Shock
  • Pancreatitis
  • Acute on Chronic Liver Failure
  • Acute Liver Failure
  • Burns
  • Chimeric Antigen Receptor T-Cell Therapy (CAR-T) Cytokine Release Syndrome (CRS)
  • Extracorporeal Life Support
  • Postoperative Endocarditis
  • Hemophagocytic Lymphohistiocytoses
  • Liver Transplant; Complications
  • Infectious Disease
  • Postoperative Vasoplegic Syndrome
  • Drug Overdose
  • Sepsis
03

In context

Shock, Septic

1,078 studies on the registry are indexed under Shock, Septic; 232 are open to participants now.

This study's planned enrollment of 3,000 is above the median of 108 across 406 observational studies indexed under Shock, Septic.

Browse Shock, Septic studies →

Lead sponsor

CytoSorbents, Inc is the lead sponsor of 9 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Critically ill patients receiving CytoSorb therapy

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Planned OR actual CytoSorb® 300 mL device utilization
  2. for prospective registry participation

Exclusion criteria

Exclusion Criteria:

  1. Use of the CytoSorb® 300 mL device for antithrombotic removal only
  2. Intraoperative use of CytoSorb® 300 mL device during cardiac surgery only
  3. The occurrence of a complication or other medically justified circumstance that arises after written 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 or no longer appropriate.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
3,000 participants (estimated)
Target follow-up
3 Months
Patient registry
Yes

Interventions

  • DeviceCytoSorb

    Sorbent hemoperfusion system

06

What researchers measure

Primary outcomes

  1. ICU mortality

    Time frame: Through ICU discharge or date of death, whichever comes first [on average 7 days]

  2. In-hospital mortality

    Time frame: Through hospital discharge or date of death, whichever comes first [on average 14 days]

07

Study locations

24 of 28 sites recruiting
  • Klinikum Klagenfurt am Wörthersee
    Klagenfurt, 9020, Austria
    Recruiting
    • Markus Köstenberger, Dr. · Principal investigator
  • Medizinische Universität Wien
    Vienna, 1090, Austria
    Recruiting
    • Martin Bernardi, ap. Prof. Priv.-Doz. Dr. Dr. · Principal investigator
  • Universitätsklinikum Aachen
    Aachen, 52074, Germany
    Recruiting
    • Alexander Koch, MD, Prof · Principal investigator
  • Herz- und Diabeteszentrum Nordrhein-Westfalen
    Bad Oeynhausen, 32545, Germany
    Recruiting
    • Thomas Kirschning, MD · Principal investigator
  • Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil Bochum
    Bochum, 44789, Germany
    Recruiting
    • Nathalie Malewicz-Oeck, MD · Principal investigator
  • Katholisches Klinikum Bochum, St. Josef-Hospital
    Bochum, 44791, Germany
    Recruiting
    • Martin Bellgardt, MD, PD · Principal investigator
  • Universitätsklinikum Essen, Medizinische Intensivtherapie
    Essen, 45147, Germany
    Recruiting
    • Bartosz Tyczynski, MD · Principal investigator
  • Universitätsklinikum Essen, Nephrologie
    Essen, 45147, Germany
    Recruiting
    • Kristin Schönfelder, MD · Principal investigator
  • Universitätsklinikum Essen, Thorax- und Kardiovaskuläre Chirurgie
    Essen, 45147, Germany
    Recruiting
    • Matthias Thielmann, MD, Prof · Principal investigator
  • Universitätsmedizin Göttingen, Allgemein-, Viszeral- und Kinderchirurgie
    Göttingen, 37075, Germany
    Recruiting
    • Thorsten Perl, MD, PD · Principal investigator
  • Universitätsmedizin Göttingen, Herzzentrum Göttingen
    Göttingen, 37075, Germany
    Recruiting
    • Aschraf El-Essawi, MD, PD · Principal investigator
  • Klinikum Herford
    Herford, 32049, Germany
    Recruiting
    • Dietrich Henzler, MD, Prof · Principal investigator
  • Universitätsklinikum Jena
    Jena, 07747, Germany
    Recruiting
    • Christian Schulze, MD, Prof · Principal investigator
  • Klinikum Kassel
    Kassel, 34125, Germany
    Withdrawn

    Not enrolling at this site — choose another above.

  • Universitätsklinikum Marburg
    Marburg, 35043, Germany
    Recruiting
    • Julian Kreutz, MD · Principal investigator
  • Kliniken Maria Hilf
    Mönchengladbach, 41063, Germany
    Terminated

    Not enrolling at this site — choose another above.

  • Deutsches Herzzentrum München
    München, 80636, Germany
    Terminated

    Not enrolling at this site — choose another above.

  • LMU Klinikum München
    München, Germany
    Recruiting
    • Christina Scharf-Janßen, MD, PD · Principal investigator
  • Klinikum Oldenburg
    Oldenburg, 26133, Germany
    Recruiting
    • Martin Tholl, MD · Principal investigator
  • Helios Dr. Horst Schmidt Kliniken Wiesbaden
    Wiesbaden, 65199, Germany
    Recruiting
    • Moritz Unglaube, MD · Principal investigator
  • Ospedale Pediatrico Bambino Gesù
    Roma, 00165, Italy
    Terminated

    Not enrolling at this site — choose another above.

  • IRCCS Ospedale Casa Sollievo della Sofferenza
    San Giovanni Rotondo, 71013, Italy
    Recruiting
    • Filippo Aucella, MD · Principal investigator
  • SP ZOZ Szpital Uniwersytecki w Krakowie
    Krakow, 30-688, Poland
    Recruiting
    • Anna Wrzosek, Dr. · Principal investigator
  • Uniwersyteckim Spitalem Klinicznym im. Jana Mikulicza - Radeckiego we Wrocławiu
    Wroclaw, 50-556, Poland
    Recruiting
    • Waldemar Goździk, Prof · Principal investigator
  • Unidade Local de Saúde de Coimbra E.P.E
    Coimbra, 3004-561, Portugal
    Recruiting
    • Ricardo André Baptista Patrício Silva Freitas, Dr. · Principal investigator
  • ULS São José, Hospital Curry Cabral
    Lisbon, Portugal
    Recruiting
    • Nuno Germano, MD · Principal investigator
  • Hospital Universitari Vall d'Hebron
    Barcelona, Barcelona 08035, Spain
    Recruiting
    • Ricard Ferrer Roca, MD · Principal investigator
  • Hospital Juan Ramón Jimenez
    Huelva, Spain
    Recruiting
    • Mario Márquez Fernández · Principal investigator
08

References and documents

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 41180104 ↗
  • Taccone 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 ↗

Individual participant data

Plan to share: No

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2022 (actual). Primary completion is estimated for Jun 2032, 120 months after the start.

Of 202 observational studies under Shock, Septic, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 47. This study's planned 120 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 23, 2021
First posted
Dec 6, 2021
StartActual
Jun 22, 2022
Primary completionEst.
Jun 2032
CompletionEst.
Sep 2032
Last update
Oct 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
Deutsches Herzzentrum München is now Terminated
Oct 20, 2026
Site contacts
Changed at 2 sites. See the sites
Show 2 sites
  • Universitätsklinikum Aachen · Aachen, GermanyContact person changed (no phone or email listed)
  • Deutsches Herzzentrum München · München, GermanyContact removed (no phone or email listed)
Oct 20, 2026
Show all 1 update
  1. Oct 20, 2026
    Deutsches Herzzentrum München is now Terminated
    Site contacts Changed at 2 sites. See the sites
    Show 2 sites
    • Universitätsklinikum Aachen · Aachen, GermanyContact person changed (no phone or email listed)
    • Deutsches Herzzentrum München · München, GermanyContact removed (no phone or email listed)
    + 2 other changes: verification date and oversight details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT05146336
Lead sponsor
CytoSorbents, Inc
Responsible party
Sponsor
First posted
Dec 6, 2021
Start date
Jun 22, 2022
Primary completion
Jun 2032 (estimated)
Completion
Sep 2032 (estimated)
Last update
Oct 20, 2026

Study contacts

Robert Wilke
Contact
cosmos@cytosorbents.com
+49 30 654 99 145
Ricard Ferrer Roca, MD
principal investigator · Hospital Vall d'Hebron

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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