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

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

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

  2. 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:

Study Results

No Results Posted as of Jul 22, 2022