Comparing Cytokines, Toxins Adsorbing oXiris Filter to ST150 Filter During CRRT in Patients With Septic Shock (oXiris)
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|ClinicalTrials.gov Identifier: NCT02600312|
Recruitment Status : Completed
First Posted : November 9, 2015
Last Update Posted : July 26, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Septic Shock Acute Kidney Injury||Device: oXiris||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Comparing Cytokines, Toxins Adsorbing oXiris Filter to ST150 Filter During CRRT in Patients With Septic Shock|
|Actual Study Start Date :||October 2015|
|Actual Primary Completion Date :||January 2018|
|Actual Study Completion Date :||January 2018|
Active Comparator: oXiris
Continuous renal replacement therapy with filter that adsorbs cytokines/toxins.
oXiris CRRT filter which adsorbs cytokines, toxins.
No Intervention: ST150
Continuous renal replacement therapy with filter that does not adsorb cytokines/toxins.
- endotoxin level in blood [ Time Frame: 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).
- mean blood pressure [ Time Frame: hourly up to 48 hours ]Additional parameter that describes the clinical impact from the septic state.
- TNF-α level in blood [ Time Frame: change from baseline to 48 hours ]Additional parameter that describes the load from the septic shock.
- IL-1β level in blood [ Time Frame: change from baseline to 48 hours ]Additional parameter that describes the load from the septic shock.
- IL-6 level in blood [ Time Frame: change from baseline to 48 hours ]Additional parameter that describes the load from the septic shock.
- IL-10 [ Time Frame: change from baseline to 48 hours ]Additional parameter that describes the load from the septic shock.
- level of vasoconstrictive infusion [ Time Frame: hourly up to 48 hours ]Need of vasoconstrictor because of shock, higher degree of shock means increased requirement of vasoconstrictor infusion.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02600312
|Perioperative and Intensive Care (Adult), Skåne University Hospital, Lund|
|Lund, Skåne, Sweden, 22241|
|Principal Investigator:||Marcus Broman, Associate professor||Dep Perioperative and Intensive Care, Skåne University Hospital, Lund, Sweden|