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CytOSorb TreatMent Of Critically Ill PatientS Registry (COSMOS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05146336
Recruitment Status : Recruiting
First Posted : December 6, 2021
Last Update Posted : March 23, 2023
Sponsor:
Information provided by (Responsible Party):
CytoSorbents, Inc

Study Description
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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

Condition or disease Intervention/treatment
Critical Illness Septic Shock Vasogenic Shock Acute Respiratory Distress Syndrome Severe Acute Respiratory Syndrome Liver Failure Trauma Rhabdomyolysis Corona Virus Infection Vasoplegic Syndrome Cardiogenic Shock Pancreatitis Device: CytoSorb

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: CytOSorb TreatMent Of Critically Ill PatientS Registry: International Registry on the Use of CytoSorb in the Critical Care Setting
Actual Study Start Date : June 22, 2022
Estimated Primary Completion Date : March 2031
Estimated Study Completion Date : June 2031

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Critical Care

Groups and Cohorts
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Intervention Details:
  • Device: CytoSorb
    Sorbent hemoperfusion system

Outcome Measures
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Primary Outcome Measures :
  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] ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Critically ill patients receiving CytoSorb therapy
Criteria

Inclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05146336


Contacts
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Contact: Antje Fechner +49 30 654 99 145 clinical@cytosorbents.com

Locations
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Germany
Universitätsklinikum Essen, Klinik für Nephrologie Recruiting
Essen, Germany, 45147
Contact: Raffaela Kirchmeyer         
Principal Investigator: Andreas Kribben, MD, Prof         
Universitätsklinikum Essen, Klinik für Thorax- und Kardiovaskuläre Chirurgie Recruiting
Essen, Germany, 45147
Contact: Wolfgang Ristau         
Principal Investigator: Matthias Thielmann, MD, Prof         
Universitätsklinikum Essen, Medizinische Intensivtherapie I Recruiting
Essen, Germany, 45147
Contact: Marina Kalaitzi         
Principal Investigator: Bartosz Tyczynski, MD         
Universitätsmedizin Göttingen, Herzzentrum Göttingen Recruiting
Göttingen, Germany, 37075
Contact: Aschraf El-Essawi         
Principal Investigator: Aschraf El-Essawi, MD, PD         
Kliniken Maria Hilf Recruiting
Mönchengladbach, Germany, 41063
Contact: Athina Gavriil         
Principal Investigator: Athina Gavriil         
Spain
Hospital Universitari Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Contact: Vanessa Casares         
Principal Investigator: Ricard Ferrer Roca, MD         
Sponsors and Collaborators
CytoSorbents, Inc
More Information
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Responsible Party: CytoSorbents, Inc
ClinicalTrials.gov Identifier: NCT05146336    
Other Study ID Numbers: O06
First Posted: December 6, 2021    Key Record Dates
Last Update Posted: March 23, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Severe Acute Respiratory Syndrome
Coronavirus Infections
Rhabdomyolysis
Pancreatitis
Liver Failure
Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Acute Lung Injury
Shock, Cardiogenic
Vasoplegia
Syndrome
Shock
Critical Illness
Disease
Pathologic Processes
 Disease Attributes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Infections
Pancreatic Diseases
Digestive System Diseases
Virus Diseases
Lung Injury
Hepatic Insufficiency
Liver Diseases
Respiratory Tract Infections
Coronaviridae Infections