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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04344080
Recruitment Status : Completed
First Posted : April 14, 2020
Last Update Posted : September 21, 2022
Sponsor:
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
COVID-19 Device: CytoSorb-Therapy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of CytoSorb Adsorber on Hemodynamic and Immunological Parameters in Critical Ill Patients With COVID-19
Actual Study Start Date : April 1, 2020
Actual Primary Completion Date : April 10, 2021
Actual Study Completion Date : April 28, 2021

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: CytoSorb-Therapy
Therapy of COVID-19 with need for extracorporeal circulation (continuous renal replacement therapy or extracorporeal membrane oxygenation) using standard of care in Addition with hemoadsorption using CytoSorb-Adsorber
 Device: CytoSorb-Therapy
Additional use of Cytosorb-Adsorber in patients with COVID-19 and need for extracorporeal circulation (continuous renal replacement therapy or extracorporeal membrane oxygenation)
No Intervention: Standard of care
Therapy of COVID-19 with need for extracorporeal circulation (continuous renal replacement therapy or extracorporeal membrane oxygenation) using standard of care


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04344080


Locations
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Germany
University Medical Center Hamburg-Eppendorf
Hamburg, Germany
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Investigators
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Principal Investigator: Stefan Kluge, MD University Hospital Hamburg-Eppendorf, Department of Intensive Care Medicine
More Information
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Additional Information:
DOI  This link exits the ClinicalTrials.gov site

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Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT04344080    
Other Study ID Numbers: CYTOCOV-19
U1111-1250-2078 ( Registry Identifier: UTN )
DRKS00021199 ( Registry Identifier: DRKS )
First Posted: April 14, 2020    Key Record Dates
Last Update Posted: September 21, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
critically ill
intensive care medicine
CytoSorb
hemoadsorption
Additional relevant MeSH terms:
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COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases