Registry of CytoSorb Therapy in COVID-19 ICU Patients

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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COVID-19

Intervention / Treatment
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* Device: CytoSorb 300 mL device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed COVID-19 Provision of CytoSorb therapy per Instructions for Use (IFU) of the CytoSorb device. Exclusion Criteria: CytoSorb therapy for diseases other than COVID-19 Survival unlikely within 24 hours (for prospectively enrolled patients)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COVID-19 ICU Patients<br> | Device: CytoSorb 300 mL device<br>* CytoSorb hemoadsorption provided via integration of the CytoSorb device into ECMO, CRRT, or hemoperfusion extracorporeal circuits.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 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 | 
| 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 |