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

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ClinicalTrials.gov Identifier: NCT04344080
Recruitment Status : Recruiting
First Posted : April 14, 2020
Last Update Posted : April 14, 2020
Sponsor:
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf

Tracking Information
First Submitted Date  ICMJE April 9, 2020
First Posted Date  ICMJE April 14, 2020
Last Update Posted Date April 14, 2020
Actual Study Start Date  ICMJE April 1, 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 9, 2020)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 9, 2020)
  • 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.
  • Lactate clearance [ Time Frame: 10 days ]
    Improving lactate clearance by lowering serum lactate levels
  • Renal replacement therapy [ Time Frame: 10 days ]
    Time with need for renal replacement therapy
  • Extracorporeal Membrane Oxygenation [ Time Frame: 10 days ]
    Time with Need for Extracorporeal Membrane Oxygenation
  • ICU length of stay [ Time Frame: 90 days ]
    ICU length of stay
  • Time on mechanical ventilation [ Time Frame: 10 days ]
    Time on mechanical ventilation
  • Cumulative catecholamine dose [ Time Frame: 10 days ]
    Cumulative catecholamine dose
  • Overall and ICU mortality [ Time Frame: 90 days ]
    Overall and ICU mortality
  • Change of plasma Interleukin-6 (IL6) level [ Time Frame: 10 days ]
    Change of plasma Interleukin-6 (IL6) level
  • Change of plasma Interleukin-10 (IL10) level [ Time Frame: 10 days ]
    Change of plasma Interleukin-10 (IL10) level
  • Change of plasma Procalcitonin (PCT) level [ Time Frame: 10 days ]
    Change of plasma Procalcitonin (PCT) level
  • Change of HLA-DR level [ Time Frame: 10 days ]
    Change of HLA-DR (Human Leukocyte Antigen - DR isotype) level of monocytes
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of CytoSorb Adsorber on Hemodynamic and Immunological Parameters in Critical Ill Patients With COVID-19
Official Title  ICMJE Effect of CytoSorb Adsorber on Hemodynamic and Immunological Parameters in Critical Ill Patients With COVID-19
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE COVID-19
Intervention  ICMJE 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)
Study Arms  ICMJE
  • 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
    Intervention: Device: CytoSorb-Therapy
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 9, 2020)
24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Dominik Jarczak, MD +49 40 741035315 d.jarczak@uke.de
Contact: Axel Nierhaus, MD +49 40 741035315 nierhaus@uke.de
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04344080
Other Study ID Numbers  ICMJE CYTOCOV-19
U1111-1250-2078 ( Registry Identifier: UTN )
DRKS00021199 ( Registry Identifier: DRKS )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Universitätsklinikum Hamburg-Eppendorf
Study Sponsor  ICMJE Universitätsklinikum Hamburg-Eppendorf
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Stefan Kluge, MD University Hospital Hamburg-Eppendorf, Department of Intensive Care Medicine
PRS Account Universitätsklinikum Hamburg-Eppendorf
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP