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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1250-2078 | Registry Identifier | UTN | |
| DRKS00021199 | Registry Identifier | DRKS |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CytoSorb-Therapy | Active Comparator | 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 |
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| Standard of care | No Intervention | Therapy of COVID-19 with need for extracorporeal circulation (continuous renal replacement therapy or extracorporeal membrane oxygenation) using standard of care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CytoSorb-Therapy | Device | Additional use of Cytosorb-Adsorber in patients with COVID-19 and need for extracorporeal circulation (continuous renal replacement therapy or extracorporeal membrane oxygenation) |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stefan Kluge, MD | University Hospital Hamburg-Eppendorf, Department of Intensive Care Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Hamburg-Eppendorf | Hamburg | Germany |
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| Label | URL |
|---|---|
| Published trial on PubMed.gov | View source |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| 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 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |