Effect of CytoSorb Adsorber on Hemodynamic and Immunological Parameters in Critical Ill Patients With COVID-19 (CYTOCOV-19)
Primary Purpose
COVID-19
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
CytoSorb-Therapy
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring critically ill, intensive care medicine, CytoSorb, hemoadsorption
Eligibility 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
Sites / Locations
- University Medical Center Hamburg-Eppendorf
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
CytoSorb-Therapy
Standard of care
Arm Description
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
Therapy of COVID-19 with need for extracorporeal circulation (continuous renal replacement therapy or extracorporeal membrane oxygenation) using standard of care
Outcomes
Primary Outcome Measures
Percentage of patients with a significant stabilization of hemodynamics for at least 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
Change in organ dysfunction
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
Improving lactate clearance by lowering serum lactate levels
Renal replacement therapy
Time with need for renal replacement therapy
Extracorporeal Membrane Oxygenation
Time with Need for Extracorporeal Membrane Oxygenation
ICU length of stay
ICU length of stay
Time on mechanical ventilation
Time on mechanical ventilation
Cumulative catecholamine dose
Cumulative catecholamine dose
Overall and ICU mortality
Overall and ICU mortality
Change of plasma Interleukin-6 (IL6) level
Change of plasma Interleukin-6 (IL6) level
Change of plasma Interleukin-10 (IL10) level
Change of plasma Interleukin-10 (IL10) level
Change of plasma Procalcitonin (PCT) level
Change of plasma Procalcitonin (PCT) level
Change of HLA-DR level
Change of HLA-DR (Human Leukocyte Antigen - DR isotype) level of monocytes
Change of TNF alpha level after ex-vivo stimulation
Change of TNF-alfa level (Tumor Necrosis Factor alpha) level after LPS (Lipopolysaccharides) stimulation as sign of monocytic immunocompetence
Full Information
NCT ID
NCT04344080
First Posted
April 9, 2020
Last Updated
September 16, 2022
Sponsor
Universitätsklinikum Hamburg-Eppendorf
1. Study Identification
Unique Protocol Identification Number
NCT04344080
Brief Title
Effect of CytoSorb Adsorber on Hemodynamic and Immunological Parameters in Critical Ill Patients With COVID-19
Acronym
CYTOCOV-19
Official Title
Effect of CytoSorb Adsorber on Hemodynamic and Immunological Parameters in Critical Ill Patients With COVID-19
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2020 (Actual)
Primary Completion Date
April 10, 2021 (Actual)
Study Completion Date
April 28, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitätsklinikum Hamburg-Eppendorf
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
critically ill, intensive care medicine, CytoSorb, hemoadsorption
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CytoSorb-Therapy
Arm Type
Active Comparator
Arm Description
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
Arm Title
Standard of care
Arm Type
No Intervention
Arm Description
Therapy of COVID-19 with need for extracorporeal circulation (continuous renal replacement therapy or extracorporeal membrane oxygenation) using standard of care
Intervention Type
Device
Intervention Name(s)
CytoSorb-Therapy
Intervention Description
Additional use of Cytosorb-Adsorber in patients with COVID-19 and need for extracorporeal circulation (continuous renal replacement therapy or extracorporeal membrane oxygenation)
Primary Outcome Measure Information:
Title
Percentage of patients with a significant stabilization of hemodynamics for at least 24 hours
Description
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
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Change in organ dysfunction
Description
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.
Time Frame
10 days
Title
Lactate clearance
Description
Improving lactate clearance by lowering serum lactate levels
Time Frame
10 days
Title
Renal replacement therapy
Description
Time with need for renal replacement therapy
Time Frame
10 days
Title
Extracorporeal Membrane Oxygenation
Description
Time with Need for Extracorporeal Membrane Oxygenation
Time Frame
10 days
Title
ICU length of stay
Description
ICU length of stay
Time Frame
90 days
Title
Time on mechanical ventilation
Description
Time on mechanical ventilation
Time Frame
10 days
Title
Cumulative catecholamine dose
Description
Cumulative catecholamine dose
Time Frame
10 days
Title
Overall and ICU mortality
Description
Overall and ICU mortality
Time Frame
90 days
Title
Change of plasma Interleukin-6 (IL6) level
Description
Change of plasma Interleukin-6 (IL6) level
Time Frame
10 days
Title
Change of plasma Interleukin-10 (IL10) level
Description
Change of plasma Interleukin-10 (IL10) level
Time Frame
10 days
Title
Change of plasma Procalcitonin (PCT) level
Description
Change of plasma Procalcitonin (PCT) level
Time Frame
10 days
Title
Change of HLA-DR level
Description
Change of HLA-DR (Human Leukocyte Antigen - DR isotype) level of monocytes
Time Frame
10 days
Title
Change of TNF alpha level after ex-vivo stimulation
Description
Change of TNF-alfa level (Tumor Necrosis Factor alpha) level after LPS (Lipopolysaccharides) stimulation as sign of monocytic immunocompetence
Time Frame
10 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan Kluge, MD
Organizational Affiliation
University Hospital Hamburg-Eppendorf, Department of Intensive Care Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Center Hamburg-Eppendorf
City
Hamburg
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/36075200/
Description
Published trial on PubMed.gov
URL
https://doi.org/10.1159/000526446
Description
DOI
Learn more about this trial
Effect of CytoSorb Adsorber on Hemodynamic and Immunological Parameters in Critical Ill Patients With COVID-19
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