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Completed

NCT Number: NCT04344080

Effect of CytoSorb Adsorber on Hemodynamic and Immunological Parameters in Critical Ill Patients With COVID-19

This prospective randomized single Center study investigates to what extent the physical elimination of the inflammatory mediators using the CytoSorb adsorber reduces the morbidity of severely and critically ill patients with Covid-19.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Critical Illness Disease Attributes Infections Lung Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center Hamburg-Eppendorf

Hamburg, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • confirmed COVID-19 disease
  • refractory shock with need for norepinephrine ≥ 0.2 μg/kg/min for MAP ≥ 65 mmHg
  • IL6 ≥ 500 ng/l
  • Indication for CRRT or ECMO

Exclusion criteria

  • Liver cirrhosis Child Pugh C
  • "do not resuscitate"-order
  • expected survival due to comorbidities < 14 days
  • pregnancy or breastfeeding
  • participation in another interventional trial

Treatment and study plan

CytoSorb-Therapy

Device

Additional use of Cytosorb-Adsorber in patients with COVID-19 and need for extracorporeal circulation (continuous renal replacement therapy or extracorporeal membrane oxygenation)

Primary outcomes

  1. Percentage of patients with a significant stabilization of hemodynamics for at least 24 hours

    Time frame: 24 hours

    Percentage of patients with a significant stabilization of hemodynamics ("shock reversal"), defined as a significant reduction of the noradrenaline dose (≤ 0.05 µg/kg/min) while maintaining mean arterial pressure ≥ 65 mmHg for at least 24 hours compared to control group

Secondary outcomes

  1. Change in organ dysfunction

    Time frame: 10 days

    Change in organ dysfunction based on "Sequential Organ Failure Assessment" (SOFA) Score The SOFA score is made of 6 variables, each representing an organ system. Each organ system is assigned a point value from 0 (normal) to 4 (high degree of dysfunction/failure) The worst physiological variables were collected serially every 24 hours of a patient's ICU admission. The "worst" measurement was defined as the measure that correlated to the highest number of points. The SOFA score ranges from 0 to 24.

  2. Lactate clearance

    Time frame: 10 days

    Improving lactate clearance by lowering serum lactate levels

  3. Renal replacement therapy

    Time frame: 10 days

    Time with need for renal replacement therapy

  4. Extracorporeal Membrane Oxygenation

    Time frame: 10 days

    Time with Need for Extracorporeal Membrane Oxygenation

  5. ICU length of stay

    Time frame: 90 days

    ICU length of stay

  6. Time on mechanical ventilation

    Time frame: 10 days

    Time on mechanical ventilation

  7. Cumulative catecholamine dose

    Time frame: 10 days

    Cumulative catecholamine dose

  8. Overall and ICU mortality

    Time frame: 90 days

    Overall and ICU mortality

  9. Change of plasma Interleukin-6 (IL6) level

    Time frame: 10 days

    Change of plasma Interleukin-6 (IL6) level

  10. Change of plasma Interleukin-10 (IL10) level

    Time frame: 10 days

    Change of plasma Interleukin-10 (IL10) level

  11. Change of plasma Procalcitonin (PCT) level

    Time frame: 10 days

    Change of plasma Procalcitonin (PCT) level

  12. Change of HLA-DR level

    Time frame: 10 days

    Change of HLA-DR (Human Leukocyte Antigen - DR isotype) level of monocytes

  13. Change of TNF alpha level after ex-vivo stimulation

    Time frame: 10 days

    Change of TNF-alfa level (Tumor Necrosis Factor alpha) level after LPS (Lipopolysaccharides) stimulation as sign of monocytic immunocompetence

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Acronym: CYTOCOV-19

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 14, 2020
Registry last updated
Sep 21, 2022

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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