This prospective randomized single center study investigates to what extent the removal of elevated cytokine levels by hemoadsorption has a positive effect on the treatment of patients in septic shock by stabilizing the circulatory situation.
The term "sepsis" refers to a clinical syndrome in which a dysregulation of the host's inflammatory reaction to infection leads to a life-threatening of organ dysfunctions. Sepsis and septic shock are major causes of death in intensive care units worldwide. The clinical picture of septic shock, the most severe form of sepsis, leads to uncontrolled production and release of a large number of proinflammatory cytokines and mediators, the "cytokine storm". Septic shock is accompanied by a massive increase in mortality of up to 60%. This high mortality rate is due to a lack of current treatment options. The early recognition of the disease and its immediate treatment are decisive for successful therapy and the survival of those affected. The most important therapeutic steps, apart from focus control by antibiotics and surgical intervention, are the stabilization of the affected organ systems, in particular the circulatory system and the respiratory system. As an extracorporeal and non-specific procedure for the interruption of the cytokine storm, hemoadsorption by means of CytoSorb adsorbers may be an intervention, which has already demonstrated its basic effectiveness in the treatment of septic and cardiosurgical patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Additional use of Cytosorb-Adsorber in patients with septic shock and need for continuous renal replacement therapy
University Medical Center Hamburg-Eppendorf
Hamburg, Germany
RECRUITINGPercentage of patients with a reduction of catecholamine dose of at least 25% within the first 48 hours of treatment
Percentage of patients with a reduction of catecholamine dose of at least 25% compared to baseline for at least 6 hours within the first 48 hours of treatment.
Time frame: 48 hours
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.
Time frame: 10 days
Lactate clearance
Improving lactate clearance by lowering serum lactate levels
Time frame: 10 days
Renal replacement therapy
Time with need for renal replacement therapy
Time frame: 10 days
Percentage of patients with a reduction of catecholamine dose of at least 25% within the first 24 hours of treatment
Percentage of patients with a reduction of catecholamine dose of at least 25% compared to baseline for at least 6 hours within the first 48 hours of treatment.
Time frame: 24 hours
End of septic shock
Time until shock resolution
Time frame: 10 days
ICU length of stay
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ICU length of stay
Time frame: 90 days
Time on mechanical ventilation
Time on mechanical ventilation
Time frame: 10 days
Cumulative catecholamine dose
Cumulative catecholamine dose
Time frame: 10 days
Overall and ICU mortality
Overall and ICU mortality
Time frame: 90 days
Serum levels of administered anti-infectives
Serum drug Levels of pre and post filter and adsorber system on day 1-3 while CytoSorb therapy (sampling: t 0, 1, 2, 6, 8, 12, 24 h after CytoSorb initiation)
Time frame: 3 days
Change of plasma Interleukin-6 (IL6) level
Change of plasma Interleukin-6 (IL6) level
Time frame: 10 days
Change of plasma Interleukin-10 (IL10) level
Change of plasma Interleukin-10 (IL10) level
Time frame: 10 days
Change of plasma Procalcitonin (PCT) level
Change of plasma Procalcitonin (PCT) level
Time frame: 10 days
Change of HLA-DR level
Change of HLA-DR (Human Leukocyte Antigen - DR isotype) level of monocytes
Time frame: 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
Time frame: 10 days