CytOSorb TreatMent Of Critically Ill PatientS Registry (COSMOS)

April 10, 2024 updated by: CytoSorbents, Inc

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
      • Aachen, Germany, 52074
        • Not yet recruiting
        • Universitätsklinikum Aachen
        • Principal Investigator:
          • Philipp Hohlstein, MD
      • Bad Oeynhausen, Germany, 32545
        • Recruiting
        • Herz- und Diabeteszentrum Nordrhein-Westfalen
        • Principal Investigator:
          • Thomas Kirschning, MD
      • Bochum, Germany, 44789
        • Recruiting
        • Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil Bochum
        • Principal Investigator:
          • Andreas Baumann, MD
      • Bochum, Germany, 44791
        • Recruiting
        • Katholisches Klinikum Bochum, St. Josef-Hospital
        • Principal Investigator:
          • Martin Bellgardt, MD
      • Essen, Germany, 45147
        • Recruiting
        • Universitätsklinikum Essen, Medizinische Intensivtherapie
        • Principal Investigator:
          • Bartosz Tyczynski, MD
      • Essen, Germany, 45147
        • Recruiting
        • Universitätsklinikum Essen, Nephrologie
        • Principal Investigator:
          • Andreas Kribben, MD, Prof
      • Essen, Germany, 45147
        • Recruiting
        • Universitätsklinikum Essen, Thorax- und Kardiovaskuläre Chirurgie
        • Principal Investigator:
          • Matthias Thielmann, MD, Prof
      • Göttingen, Germany, 37075
        • Recruiting
        • Universitätsmedizin Göttingen, Herzzentrum Göttingen
        • Principal Investigator:
          • Aschraf El-Essawi, MD, PD
      • Herford, Germany, 32049
        • Recruiting
        • Klinikum Herford
        • Principal Investigator:
          • Dietrich Henzler, MD, Prof
      • Kassel, Germany, 34125
        • Withdrawn
        • Klinikum Kassel
      • Marburg, Germany, 35043
        • Recruiting
        • Universitätsklinikum Marburg
        • Principal Investigator:
          • Julian Kreutz, MD
      • Mönchengladbach, Germany, 41063
        • Recruiting
        • Kliniken Maria Hilf
        • Principal Investigator:
          • Athina Gavriil
      • München, Germany, 80636
        • Recruiting
        • Deutsches Herzzentrum München
        • Principal Investigator:
          • Thomas Günther, MD, PD
      • München, Germany
        • Recruiting
        • LMU Klinikum München
        • Principal Investigator:
          • Christina Scharf-Janßen, MD, PD
      • Oldenburg, Germany, 26133
        • Recruiting
        • Klinikum Oldenburg
        • Principal Investigator:
          • Ulf Günther, MD, PD
      • Wiesbaden, Germany, 65199
        • Recruiting
        • Helios Dr. Horst Schmidt Kliniken Wiesbaden
        • Principal Investigator:
          • Moritz Unglaube, MD
  • Italy
      • Roma, Italy, 00165
        • Recruiting
        • Ospedale Pediatrico Bambino Gesù
        • Principal Investigator:
          • Gabriella Bottari, MD
      • San Giovanni Rotondo, Italy, 71013
        • Recruiting
        • IRCCS Ospedale Casa Sollievo della Sofferenza
        • Principal Investigator:
          • Filippo Aucella, MD
  • Portugal
      • Lisboa, Portugal
        • Not yet recruiting
        • CHULC, Hospital Curry Cabral
        • Principal Investigator:
          • Nuno Germano, MD
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron
        • Principal Investigator:
          • Ricard Ferrer Roca, MD
      • Huelva, Spain
        • Not yet recruiting
        • Hospital Juan Ramón Jimenez
        • Principal Investigator:
          • Mario Márquez Fernández

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Critically ill patients receiving CytoSorb therapy

Description

Inclusion Criteria:

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

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 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
ICU mortality
Time Frame: Through ICU discharge or date of death, whichever comes first [on average 7 days]
Through ICU discharge or date of death, whichever comes first [on average 7 days]
In-hospital mortality
Time Frame: Through hospital discharge or date of death, whichever comes first [on average 14 days]
Through hospital discharge or date of death, whichever comes first [on average 14 days]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CytoSorbents, Inc

Investigators

  • Principal Investigator: Ricard Ferrer Roca, MD, Hospital Vall d'Hebron

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 22, 2022

Primary Completion (Estimated)

June 1, 2032

Study Completion (Estimated)

September 1, 2032

Study Registration Dates

First Submitted

November 23, 2021

First Submitted That Met QC Criteria

November 23, 2021

First Posted (Actual)

December 6, 2021

Study Record Updates

Last Update Posted (Actual)

April 11, 2024

Last Update Submitted That Met QC Criteria

April 10, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • O06

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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