Clinical trial NCT02600312: Comparing Cytokines, Toxins Adsorbing oXiris Filter to ST150 Filter During CRRT in Patients With Septic Shock
Official title: Comparing Cytokines, Toxins Adsorbing oXiris Filter to ST150 Filter During CRRT in Patients With Septic Shock
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Septic Shock
Acute Kidney Injury
Lead sponsor: Skane University Hospital
Sponsor class: OTHER
First posted: 2015-11-09
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: endotoxin level in blood
timeFrame: change from baseline to 48 hours
Secondary outcomes:
measure: mean blood pressure
timeFrame: hourly up to 48 hours
measure: TNF-α level in blood
timeFrame: change from baseline to 48 hours
measure: IL-1β level in blood
timeFrame: change from baseline to 48 hours
measure: IL-6 level in blood
timeFrame: change from baseline to 48 hours
measure: IL-10
timeFrame: change from baseline to 48 hours
Other outcomes:
measure: level of vasoconstrictive infusion
timeFrame: hourly up to 48 hours
Locations:
city: Lund
country: Sweden
facility: Perioperative and Intensive Care (Adult), Skåne University Hospital, Lund
state: Skåne
Study officials:
affiliation: Dep Perioperative and Intensive Care, Skåne University Hospital, Lund, Sweden
name: Marcus Broman, Associate professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.