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Completed

NCT Number: NCT04391920

Registry of CytoSorb Therapy in COVID-19 ICU Patients

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical Center of Aurora, Aurora, Colorado, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

CytoSorb 300 mL device

Device

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

Primary outcomes

  1. 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

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

CytoSorbents, Inc

Industry

Collaborators

  • CytoSorbents Europe GmbH

Registry information

Official study 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

Acronym: CTC REGISTRY

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
May 18, 2020
Registry last updated
Feb 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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