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

Study Overview
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Brief Summary
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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.

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

Conditions
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COVID-19

Intervention / Treatment
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* Device: CytoSorb-Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CytoSorb-Therapy<br>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<br>* Additional use of Cytosorb-Adsorber in patients with COVID-19 and need for extracorporeal circulation (continuous renal replacement therapy or extracorporeal membrane oxygenation)<br>|
| No Intervention: Standard of care<br>Therapy of COVID-19 with need for extracorporeal circulation (continuous renal replacement therapy or extracorporeal membrane oxygenation) using standard of care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 10 days | 
| Lactate clearance | Improving lactate clearance by lowering serum lactate levels | 10 days | 
| Renal replacement therapy | Time with need for renal replacement therapy | 10 days | 
| Extracorporeal Membrane Oxygenation | Time with Need for Extracorporeal Membrane Oxygenation | 10 days | 
| ICU length of stay | ICU length of stay | 90 days | 
| Time on mechanical ventilation | Time on mechanical ventilation | 10 days | 
| Cumulative catecholamine dose | Cumulative catecholamine dose | 10 days | 
| Overall and ICU mortality | Overall and ICU mortality | 90 days | 
| Change of plasma Interleukin-6 (IL6) level | Change of plasma Interleukin-6 (IL6) level | 10 days | 
| Change of plasma Interleukin-10 (IL10) level | Change of plasma Interleukin-10 (IL10) level | 10 days | 
| Change of plasma Procalcitonin (PCT) level | Change of plasma Procalcitonin (PCT) level | 10 days | 
| Change of HLA-DR level | Change of HLA-DR (Human Leukocyte Antigen - DR isotype) level of monocytes | 10 days | 
| 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 | 10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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critically ill, intensive care medicine, CytoSorb, hemoadsorption