Clinical trial NCT04391920: Registry of CytoSorb Therapy in COVID-19 ICU Patients
Official title: Registry of CytoSorb Therapy in COVID-19 ICU Patients (CTC REGISTRY): Registry of Patient-level Clinical Data on CytoSorb Hemoadsorption Provided Via Integration of the CytoSorb Device Into Extracorporeal Membrane Oxygenation (ECMO), Continuous Renal Replacement Therapy (CRRT), or Hemoperfusion Extracorporeal Circuits in COVID-19 ICU Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Lead sponsor: CytoSorbents, Inc
Sponsor class: INDUSTRY
Collaborators: name: CytoSorbents Europe GmbH
First posted: 2020-05-18
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COVID-19 ICU patients receiving CytoSorb hemoadsorption via integration of the CytoSorb device into ECMO, CRRT, or hemoperfusion extracorporeal circuits.

Brief summary: The CTC Registry collects patient-level clinical data on CytoSorb hemoadsorption provided to COVID-19 ICU patients via integration of the CytoSorb device into ECMO, CRRT, or hemoperfusion extracorporeal circuits. The intent of the registry is to gain understanding on how CytoSorb hemoadsorption provides clinical benefit to COVID-19 ICU patients.


Eligibility criteria: Inclusion Criteria:

1. Confirmed COVID-19
2. Provision of CytoSorb therapy per Instructions for Use (IFU) of the CytoSorb device.

Exclusion Criteria:

1. CytoSorb therapy for diseases other than COVID-19
2. Survival unlikely within 24 hours (for prospectively enrolled patients)

Primary outcomes:
measure: ICU mortality
timeFrame: From the date of start of CytoSorb use until the date of ICU discharge or date of death, whichever comes first, assessed up to 1 year
Secondary outcomes:
measure: Duration of ECMO after start of CytoSorb
timeFrame: From the date of start of CytoSorb use until the date of cessation of ECMO or date of death, which ever comes first, assessed up to 1 year
measure: Duration of mechanical ventilatory support after start of CytoSorb
timeFrame: From the date of start of CytoSorb use until the date of cessation of mechanical ventilatory support or date of death, which ever comes first, assessed up to 1 year
measure: Duration of pharmacologic hemodynamic support after start of CytoSorb
timeFrame: From the date of start of CytoSorb use until the date of cessation of pharmacologic hemodynamic support or date of death, which ever comes first, assessed up to 1 year
measure: Change in serum concentrations of inflammatory biomarkers after start of CytoSorb
timeFrame: From the day before start of CytoSorb use until the day after cessation of CytoSorb use
measure: Change in Pa02/Fi02 ratio after start of CytoSorb
timeFrame: From the day before start of CytoSorb use until the day after cessation of CytoSorb use
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Medical Center of Aurora
state: Colorado
city: Chicago
country: United States
facility: University of Chicago Medicine
state: Illinois
city: Indianapolis
country: United States
facility: Franciscan Health Indianapolis
state: Indiana
city: Southaven
country: United States
facility: Baptist Memorial Hospital
state: Mississippi
city: New York
country: United States
facility: New York University Medical Center
state: New York
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: CytoSorbents Corporation
name: Peter Nelson, MD
role: STUDY_DIRECTOR
References:
citation: Song T, Hayanga J, Durham L, Garrison L, McCarthy P, Barksdale A, Smith D, Bartlett R, Jaros M, Nelson P, Molnar Z, Deliargyris E, Moazami N. CytoSorb Therapy in COVID-19 (CTC) Patients Requiring Extracorporeal Membrane Oxygenation: A Multicenter, Retrospective Registry. Front Med (Lausanne). 2021 Dec 20;8:773461. doi: 10.3389/fmed.2021.773461. eCollection 2021.