Registry of CytoSorb Therapy in COVID-19 ICU Patients

N/ACompletedNCT04391920

CytoSorbents, Inc138 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

138

Conditions

COVID-19

Interventions

CytoSorb 300 mL deviceDEVICE

CytoSorb hemoadsorption provided via integration of the CytoSorb device into ECMO, CRRT, or hemoperfusion extracorporeal circuits.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

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

Baptist Memorial Hospital

Southaven, Mississippi, United States

Outcomes

Primary Outcomes

ICU mortality

Time frame: 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

Duration of ECMO after start of CytoSorb

Time frame: 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

Duration of mechanical ventilatory support after start of CytoSorb

Time frame: 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

Duration of pharmacologic hemodynamic support after start of CytoSorb

Time frame: 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 serum concentrations of inflammatory biomarkers after start of CytoSorb

Time frame: From the day before start of CytoSorb use until the day after cessation of CytoSorb use

Change in Pa02/Fi02 ratio after start of CytoSorb

Time frame: From the day before start of CytoSorb use until the day after cessation of CytoSorb use

Data from ClinicalTrials.gov

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