Registry of CytoSorb Therapy in COVID-19 ICU Patients

Completed

• Conditions: COVID-19
• Interventions: Device: CytoSorb 300 mL device

• Registration Number: NCT04391920
• Lead Sponsor: CytoSorbents, Inc

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-12
• Study First Submitted QC: 2020-05-15
• Study First Posted: 2020-05-18
• Study Start: 2020-08-28
• Status Verified: 2022-01
• Primary Completion: 2022-01-20
• Study Completion: 2022-01-20
• Last Update Submitted: 2024-02-07
• Last Update Posted: 2024-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 138

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COVID-19 ICU Patients	CytoSorb 300 mL device	-

Primary Outcome Measures

Name	Time	Method
ICU mortality	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 Outcome Measures

Name	Time	Method
Duration of mechanical ventilatory support after start of CytoSorb	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
Change in serum concentrations of inflammatory biomarkers after start of CytoSorb	From the day before start of CytoSorb use until the day after cessation of CytoSorb use
Duration of pharmacologic hemodynamic support after start of CytoSorb	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
Change in Pa02/Fi02 ratio after start of CytoSorb	From the day before start of CytoSorb use until the day after cessation of CytoSorb use
Duration of ECMO after start of CytoSorb	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

Trial Locations

Locations (7)

Medical Center of Aurora; 🇺🇸 Aurora, Colorado, United States

University of Chicago Medicine; 🇺🇸 Chicago, Illinois, United States

Franciscan Health Indianapolis; 🇺🇸 Indianapolis, Indiana, United States

West Virginia University; 🇺🇸 Morgantown, West Virginia, United States

Baptist Memorial Hospital; 🇺🇸 Southaven, Mississippi, United States

New York University Medical Center; 🇺🇸 New York, New York, United States

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States