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

Acute Kidney Injury Clinical Trial

— oXiris  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02600312
• Other study ID #: oXiris
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: January 2018

Study information

• Verified date: July 2019
• Source: Skane University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Kidney Injury
• Septic Shock
• Shock
• Shock, Septic

Intervention

Device:
• oXiris
oXiris CRRT filter which adsorbs cytokines, toxins.

Locations

Country	Name	City	State
Sweden	Perioperative and Intensive Care (Adult), Skåne University Hospital, Lund	Lund	Skåne

Sponsors (1)

Lead Sponsor	Collaborator
Skane University Hospital

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Secondary	mean blood pressure	Additional parameter that describes the clinical impact from the septic state.	hourly up to 48 hours
Secondary	TNF-a level in blood	Additional parameter that describes the load from the septic shock.	change from baseline to 48 hours
Secondary	IL-1ß level in blood	Additional parameter that describes the load from the septic shock.	change from baseline to 48 hours
Secondary	IL-6 level in blood	Additional parameter that describes the load from the septic shock.	change from baseline to 48 hours
Secondary	IL-10	Additional parameter that describes the load from the septic shock.	change from baseline to 48 hours