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The aim of the study is to investigate the effect of CytoSorb® treatment within the first 48 hours of septic shock on organ dysfunction, microcirculation and on the cytokine storm as monitored by leukocyte activation and inflammatory mediators.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CytoSorb | Patients with septic shock will get routine ICU care supported by CytoSorb® treatment. |
| |
| Control | Patients with septic shock will get routine ICU care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CytoSorb 300ml device (3804606CE01) | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cytokine response | Cytokine response: procalcitonin, C-reactive protein, interleukin-1, interleukin-1ra, interleukin-6, interleukin-8, interleukin-10, Tumor Necrosis Factor- α | First 48 hours of septic shock |
| Organ dysfunctions | Organ dysfunctions: SOFA-scores, neurologic function (Glasgow coma scale), hemodynamic function (PiCCO parameters, ScvO2, lactate, dCO2), pulmonary function (gas exchange, pulmonary mechanics, Acute Respiratory Distress Syndrome classification (BERLIN)), renal function (KDIGO-, RIFLE-scores), gastrointestinal function (liver, GIT function, hematology (hemostasis, qualitative blood count) | First 48 hours of septic shock |
| Measure | Description | Time Frame |
|---|---|---|
| Leukocyte function | Leukocyte function: heterogeneity of leukocyte cell population in the bloodstream, T-cell activation and apoptosis, leukocyte inflammatory markers expression | First 48 hours of septic shock |
| Microcirculation |
| Measure | Description | Time Frame |
|---|---|---|
| Length of intensive care unit stay, | First 48 hours of septic shock | |
| Length of hospital stay | First 48 hours of septic shock | |
| Mortality |
Inclusion Criteria:
Exclusion Criteria:
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ICU patients with septic shock of medical origin
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anaesthesiology and Intensive Therapy | Szeged | Csongrád megye | H-6725 | Hungary |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30448517 | Derived | Hawchar F, Laszlo I, Oveges N, Trasy D, Ondrik Z, Molnar Z. Extracorporeal cytokine adsorption in septic shock: A proof of concept randomized, controlled pilot study. J Crit Care. 2019 Feb;49:172-178. doi: 10.1016/j.jcrc.2018.11.003. Epub 2018 Nov 10. |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| D012772 | Shock, Septic |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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Microcirculation: orthogonal polarization spectroscopy (OPS), gastric tonometry
| First 48 hours of septic shock |
| First 48 hours of septic shock |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |