Trial document





This trial has been registered retrospectively.
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  DRKS00021199

Trial Description

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Title

Effect of CytoSorb adsorber on hemodynamic and immunological parameters in critical ill patients with COVID-19

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Trial Acronym

CYTOCOV-19

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The aim of this clinical study is to evaluate to what extent the physical elimination of the inflammatory mediators by means of the CytoSorb adsorber reduces the morbidity of severely and critically ill Covid-19 patients. In addition, it will be investigated to what extent the removal of elevated cytokine levels from the bloodstream by hemoadsorption has a positive influence on the treatment of critically ill patients due to COVID-19 disease by stabilizing the circulatory situation.

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Brief Summary in Scientific Language

The aim of this clinical study is to evaluate to what extent the physical elimination of the inflammatory mediators by means of the CytoSorb adsorber reduces the morbidity of critically and critically ill Covid-19 patients. In addition, it will be investigated to what extent the removal of elevated cytokine levels from the bloodstream by hemoadsorption using the CytoSorb Adsorber has a positive influence on the treatment of critically ill patients due to COVID-19 disease by stabilizing the circulatory situation.

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

[---]*

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Organizational Data

  •   DRKS00021199
  •   2020/05/07
  •   [---]*
  •   yes
  •   Approved
  •   PV7314, Ethik-Kommission der Ärztekammer Hamburg
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Secondary IDs

  •   U1111-1250-2078 
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Health Condition or Problem studied

  •   U07.1 -  Emergency use of U07.1
  •   COVID-19
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Interventions/Observational Groups

  •   Patients with confirmed COVID-19, refractory shock and continuous renal replacement therapy or extracorporeal Membrane oxygenation, additional therapy with
    CytoSorb hemoadsorption
  •   Patients with confirmed COVID-19, refractory shock and continuous renal replacement therapy or extracorporeal Membrane oxygenation
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

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

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Secondary Outcome

1. change in organ function by day 10 or dismissal from ICU, assessment based on SOFA score
2. improving lactate clearance by lowering serum lactate Levels
3. duration of renal replacement procedure
4. Duration of extracorporeal Membrane oxygenation procedure
5. reducing the length of stay in intensive care unit
6. reducing the length of mechanical Ventilation
7. cumulative catecholamine dose
8. Overall mortality and mortality in intensive care unit after 28 and 90 days
9. Change of plasma Interleukin-6 (IL6) level
10. Change of plasma Interleukin-10 (IL10) Level
11. Change of plasma Procalcitonin (PCT) level
12. Change of HLA-DR (Human Leukocyte Antigen - DR isotype) level of monocytes
13. Change of TNF alpha level after ex-vivo stimulation with LPS

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2020/04/01
  •   24
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   90   Years
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Additional Inclusion Criteria

1. Confirmed COVID-19
2. refractory shock (mean arterial pressure ≤ 65mmHg due to vasopressor therapy and adequate volume resuscitation; norepinephrine ≥ 0.2µg/kg bodyweight; Interleukine-6 ≥ 500ng/l
3. indication for continuous renal replacement procedure pr extracorporeal membrane oxygenation
4. age ≥ 18 years and ≤ 90 years

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Exclusion Criteria

1. Liver Cirrhosis Child-Pugh C
2. therapy restriction (DNR), moribund patient
3. expected survival due to concomitant diseases ≤ 14 days
4. pregnancy or lactation
5. participation in another interventional study

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Addresses

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    • Universitätsklinikum Hamburg Eppendorf
    • Martinistrasse 52
    • 20246  Hamburg
    • Germany
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    • Universitätsklinikum Hamburg-Eppendorf, Klinik für Intensivmedizin
    • Mr.  Dr. med.  Dominik  Jarczak 
    • Martinistr. 52
    • 20246  Hamburg
    • Germany
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    • Universitätsklinikum Hamburg-Eppendorf, Klinik für Intensivmedizin
    • Mr.  Dr. med.  Dominik  Jarczak 
    • Martinistr. 52
    • 20246  Hamburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Hamburg-Eppendorf, Klinik für Intensivmedizin
    • Mr.  Dr. med.  Dominik  Jarczak 
    • Martinistr. 52
    • 20246  Hamburg
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
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  •   24
  •   24
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.