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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| oXiris | Active Comparator | Continuous renal replacement therapy with filter that adsorbs cytokines/toxins. |
|
| ST150 | No Intervention | Continuous renal replacement therapy with filter that does not adsorb cytokines/toxins. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oXiris | Device | oXiris CRRT filter which adsorbs cytokines, toxins. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | change from baseline to 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| mean blood pressure | Additional parameter that describes the clinical impact from the septic state. | hourly up to 48 hours |
| TNF-α level in blood | Additional parameter that describes the load from the septic shock. |
| Measure | Description | Time Frame |
|---|---|---|
| level of vasoconstrictive infusion | Need of vasoconstrictor because of shock, higher degree of shock means increased requirement of vasoconstrictor infusion. | hourly up to 48 hours |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marcus Broman, Associate professor | Dep Perioperative and Intensive Care, Skåne University Hospital, Lund, Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Perioperative and Intensive Care (Adult), Skåne University Hospital, Lund | Lund | Skåne County | 22241 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21893976 | Result | Ala-Kokko TI, Laurila J, Koskenkari J. A new endotoxin adsorber in septic shock: observational case series. Blood Purif. 2011;32(4):303-9. doi: 10.1159/000330323. Epub 2011 Sep 2. | |
| 34519356 | Derived | Tsujimoto Y, Miki S, Shimada H, Tsujimoto H, Yasuda H, Kataoka Y, Fujii T. Non-pharmacological interventions for preventing clotting of extracorporeal circuits during continuous renal replacement therapy. Cochrane Database Syst Rev. 2021 Sep 14;9(9):CD013330. doi: 10.1002/14651858.CD013330.pub2. |
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| ID | Term |
|---|---|
| D012772 | Shock, Septic |
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
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| change from baseline to 48 hours |
| IL-1β level in blood | Additional parameter that describes the load from the septic shock. | change from baseline to 48 hours |
| IL-6 level in blood | Additional parameter that describes the load from the septic shock. | change from baseline to 48 hours |
| IL-10 | Additional parameter that describes the load from the septic shock. | change from baseline to 48 hours |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |