COVID-19
Conditions
Keywords
critically ill, intensive care medicine, CytoSorb, hemoadsorption
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.
Interventions
DEVICECytoSorb-Therapy
Additional use of Cytosorb-Adsorber in patients with COVID-19 and need for extracorporeal circulation (continuous renal replacement therapy or extracorporeal membrane oxygenation)
Sponsors
Universitätsklinikum Hamburg-Eppendorf
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients with a significant stabilization of hemodynamics for at least 24 hours | 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
| Measure | Time frame | Description |
|---|---|---|
| Change of plasma Procalcitonin (PCT) level | 10 days | Change of plasma Procalcitonin (PCT) level |
| Change of HLA-DR level | 10 days | Change of HLA-DR (Human Leukocyte Antigen - DR isotype) level of monocytes |
| Change in organ dysfunction | 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 | 10 days | Improving lactate clearance by lowering serum lactate levels |
| Renal replacement therapy | 10 days | Time with need for renal replacement therapy |
| Extracorporeal Membrane Oxygenation | 10 days | Time with Need for Extracorporeal Membrane Oxygenation |
| Change of plasma Interleukin-10 (IL10) level | 10 days | Change of plasma Interleukin-10 (IL10) level |
| Time on mechanical ventilation | 10 days | Time on mechanical ventilation |
| Cumulative catecholamine dose | 10 days | Cumulative catecholamine dose |
| Overall and ICU mortality | 90 days | Overall and ICU mortality |
| Change of plasma Interleukin-6 (IL6) level | 10 days | Change of plasma Interleukin-6 (IL6) level |
| Change of TNF alpha level after ex-vivo stimulation | 10 days | Change of TNF-alfa level (Tumor Necrosis Factor alpha) level after LPS (Lipopolysaccharides) stimulation as sign of monocytic immunocompetence |
| ICU length of stay | 90 days | ICU length of stay |
Countries
Germany
Outcome results
None listed