Comparing Cytokines, Toxins Adsorbing oXiris Filter to ST150 Filter During CRRT in Patients With Septic Shock

Not Applicable

Completed

• Conditions: Septic Shock; Acute Kidney Injury
• Interventions: Device: oXiris

• Registration Number: NCT02600312
• Lead Sponsor: Skane University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-30
• Study First Submitted QC: 2015-11-06
• Study First Posted: 2015-11-09
• Primary Completion: 2018-01
• Study Completion: 2018-01
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-25
• Last Update Posted: 2019-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
oXiris	oXiris	Continuous renal replacement therapy with filter that adsorbs cytokines/toxins.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
mean blood pressure	hourly up to 48 hours	Additional parameter that describes the clinical impact from the septic state.
IL-1β 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.
TNF-α 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.

Trial Locations

Locations (1)

Perioperative and Intensive Care (Adult), Skåne University Hospital, Lund; 🇸🇪 Lund, Skåne, Sweden