Acute Kidney Injury, Septic Shock
Conditions
Brief summary
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.
Interventions
DEVICEoXiris
oXiris CRRT filter which adsorbs cytokines, toxins.
Sponsors
Skane University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients admitted to intensive care unit (ICU) of age \>18 years with decision based on the clinical situation of the patient taken by the physician in charge that continuous renal replacement therapy will be started. 2. Vasoconstrictor and volume dependent septic shock with known Gram-negative infectious agent in blood culture. 3. Vasoconstrictor and volume dependent septic shock suspected to be caused by a Gram-negative agent and with positive plasma endotoxin test.
Exclusion criteria
1. Infected with Hepatitis B or C or HIV. 2. Dependence on dialysis treatment before the actual ICU episode.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| endotoxin level in blood | change from baseline to 48 hours | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| mean blood pressure | hourly up to 48 hours | Additional parameter that describes the clinical impact from the septic state. |
| TNF-α level in blood | change from baseline to 48 hours | Additional parameter that describes the load from the septic shock. |
| IL-6 level in blood | change from baseline to 48 hours | Additional parameter that describes the load from the septic shock. |
| IL-10 | change from baseline to 48 hours | Additional parameter that describes the load from the septic shock. |
| IL-1β level in blood | change from baseline to 48 hours | Additional parameter that describes the load from the septic shock. |
Other
| Measure | Time frame | Description |
|---|---|---|
| level of vasoconstrictive infusion | hourly up to 48 hours | Need of vasoconstrictor because of shock, higher degree of shock means increased requirement of vasoconstrictor infusion. |
Countries
Sweden
Outcome results
None listed