COSMOS: CytOSorb TreatMent Of Critically Ill PatientS Registry
Sponsor
CytoSorbents, Inc (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05146336
Collaborator
(none)
3,000
2
107.3
1500
14
Study Details
Study Description
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 | Phase |
---|---|---|
|
Study Design
Study Type:
Observational [Patient Registry]
Anticipated Enrollment
:
3000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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
:
Jun 22, 2022
Anticipated Primary Completion Date
:
Mar 1, 2031
Anticipated Study Completion Date
:
Jun 1, 2031
Outcome Measures
Primary Outcome Measures
- 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]]
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
CytoSorb utilization in the setting of critical illness
-
Informed consent for prospective registry participation
Exclusion Criteria:
-
Use of the CytoSorb device for antithrombotic removal
-
Use of the CytoSorb device during cardiac surgery
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Universitätsklinikum Essen | Essen | North Rhine-Westphalia | Germany | 45147 |
2 | Hospital Universitari Vall d'Hebron | Barcelona | Spain | 08035 |
Sponsors and Collaborators
- CytoSorbents, Inc
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
CytoSorbents, Inc
ClinicalTrials.gov Identifier:
NCT05146336
Other Study ID Numbers:
- O06
First Posted:
Dec 6, 2021
Last Update Posted:
Jul 22, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: