CytOSorb TreatMent Of Critically Ill PatientS Registry

NCT05146336 | Recruiting DMC

• 1 other identifier: O06
• Study Type: observational
• Target: 3,000
• Locations: 6 countries
• Sites: 28

Brief 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

Conditions

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

Outcome Measures

Primary Outcomes (2)

• ICU mortality

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

• In-hospital mortality

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

Interventions

CytoSorb DEVICE

Sorbent hemoperfusion system

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Critically ill patients receiving CytoSorb therapy

You may qualify if:

• Planned OR actual CytoSorb® 300 mL device utilization
• Informed consent for prospective registry participation

You may not qualify if:

• 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.

Sponsors & Collaborators

• CytoSorbents, Inc: lead

Study Sites (28)

Klinikum Klagenfurt am Wörthersee

Klagenfurt, 9020, Austria

RECRUITING

Medizinische Universität Wien

Vienna, 1090, Austria

RECRUITING

Universitätsklinikum Aachen

Aachen, 52074, Germany

RECRUITING

Herz- und Diabeteszentrum Nordrhein-Westfalen

Bad Oeynhausen, 32545, Germany

RECRUITING

Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil Bochum

Bochum, 44789, Germany

RECRUITING

Katholisches Klinikum Bochum, St. Josef-Hospital

Bochum, 44791, Germany

RECRUITING

Universitätsklinikum Essen, Medizinische Intensivtherapie

Essen, 45147, Germany

RECRUITING

Universitätsklinikum Essen, Nephrologie

Essen, 45147, Germany

RECRUITING

Universitätsklinikum Essen, Thorax- und Kardiovaskuläre Chirurgie

Essen, 45147, Germany

RECRUITING

Universitätsmedizin Göttingen, Allgemein-, Viszeral- und Kinderchirurgie

Göttingen, 37075, Germany

RECRUITING

Universitätsmedizin Göttingen, Herzzentrum Göttingen

Göttingen, 37075, Germany

RECRUITING

Klinikum Herford

Herford, 32049, Germany

RECRUITING

Universitätsklinikum Jena

Jena, 07747, Germany

RECRUITING

Klinikum Kassel

Kassel, 34125, Germany

WITHDRAWN

Universitätsklinikum Marburg

Marburg, 35043, Germany

RECRUITING

Kliniken Maria Hilf

Mönchengladbach, 41063, Germany

TERMINATED

Deutsches Herzzentrum München

München, 80636, Germany

RECRUITING

LMU Klinikum München

München, Germany

RECRUITING

Klinikum Oldenburg

Oldenburg, 26133, Germany

RECRUITING

Helios Dr. Horst Schmidt Kliniken Wiesbaden

Wiesbaden, 65199, Germany

RECRUITING

Ospedale Pediatrico Bambino Gesù

Roma, 00165, Italy

TERMINATED

IRCCS Ospedale Casa Sollievo della Sofferenza

San Giovanni Rotondo, 71013, Italy

RECRUITING

SP ZOZ Szpital Uniwersytecki w Krakowie

Krakow, 30-688, Poland

RECRUITING

Uniwersyteckim Spitalem Klinicznym im. Jana Mikulicza - Radeckiego we Wrocławiu

Wroclaw, 50-556, Poland

RECRUITING

Unidade Local de Saúde de Coimbra E.P.E

Coimbra, 3004-561, Portugal

RECRUITING

ULS São José, Hospital Curry Cabral

Lisbon, Portugal

RECRUITING

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona, 08035, Spain

RECRUITING

Hospital Juan Ramón Jimenez

Huelva, Spain

RECRUITING

Related Publications (2)

• 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.

  PMID: 41180104 DERIVED

• 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.

  PMID: 39500494 DERIVED

MeSH Terms

Conditions

Shock, Septic; Respiratory Distress Syndrome; Wounds and Injuries; Rhabdomyolysis; Shock, Cardiogenic; Pancreatitis; Acute-On-Chronic Liver Failure; Liver Failure, Acute; Burns; Cytokine Release Syndrome; Lymphohistiocytosis, Hemophagocytic; Communicable Diseases; Vasoplegia; Drug Overdose; Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Muscular Diseases; Musculoskeletal Diseases; Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Necrosis; Pancreatic Diseases; Digestive System Diseases; Liver Failure; Hepatic Insufficiency; Liver Diseases; Histiocytosis, Non-Langerhans-Cell; Histiocytosis; Lymphatic Diseases; Hemic and Lymphatic Diseases; Disease Attributes; Postoperative Complications; Prescription Drug Misuse; Drug Misuse; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Ricard Ferrer Roca, MD

  Hospital Vall d'Hebron

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert Wilke

CONTACT

+49 30 654 99 145; cosmos@cytosorbents.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2021
• First Posted: December 6, 2021
• Study Start: June 22, 2022
• Primary Completion (Estimated): June 1, 2032
• Study Completion (Estimated): September 1, 2032
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (18); ES (2); IT (2); AU (2); PL (2); PT (2)