The Oxiris® filter is a registered product for CRRT already safely used in routine care. In in vitro experiments, the Oxiris® filter has been demonstrated to adsorb endotoxin and cytokines. Compared to conventional filters this may be advantageous in patients with severe sepsis but neither decreased levels of endotoxin and cytokines nor an improved outcome has been demonstrated with clinical use. But there are so far little clinical data on the oXiris® filter on humans. The oXiris® filter will be investigated in a double blind randomized crossover setting against a traditional filter (ST150). Either filter will be used for 24 hours after which it will be changed to the opposite filter for another 24 hours. Arterial blood samples will be drawn at start and then 1, 3, 8, 16 and 24 hours after the start of each filter, and analyzed for endotoxin (EAA assay), TNF-α, IL-1β, IL-6 and IL-10 (ELISA) levels. Standard blood tests will be analyzed simultaneously. Data concerning mode and settings of CRRT, heart rate, blood pressure, medication, data concerning ventilatory support and pathogen will be registered. Primary endpoint: Levels of endotoxin and cytokines will be compared using Student's paired t-test on AUC values for each 24-hour period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
16
oXiris CRRT filter which adsorbs cytokines, toxins.
Perioperative and Intensive Care (Adult), Skåne University Hospital, Lund
Lund, Skåne County, Sweden
endotoxin level in blood
Describes the load of toxins from the septic state. Higher load means increased impact from the infectious state mediated through the septic shock. Expected mean differences in endotoxin levels including standard deviation is based on data from a previous study on extracorporeal endotoxin removal in sepsis patients (reference 1).
Time frame: change from baseline to 48 hours
mean blood pressure
Additional parameter that describes the clinical impact from the septic state.
Time frame: hourly up to 48 hours
TNF-α level in blood
Additional parameter that describes the load from the septic shock.
Time frame: change from baseline to 48 hours
IL-1β level in blood
Additional parameter that describes the load from the septic shock.
Time frame: change from baseline to 48 hours
IL-6 level in blood
Additional parameter that describes the load from the septic shock.
Time frame: change from baseline to 48 hours
IL-10
Additional parameter that describes the load from the septic shock.
Time frame: change from baseline to 48 hours
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