Comparing Cytokines, Toxins Adsorbing oXiris Filter to ST150 Filter During CRRT in Patients With Septic Shock (oXiris)
Primary Purpose
Septic Shock, Acute Kidney Injury
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
oXiris
Sponsored by
About this trial
This is an interventional treatment trial for Septic Shock
Eligibility Criteria
Inclusion Criteria:
- 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.
- Vasoconstrictor and volume dependent septic shock with known Gram-negative infectious agent in blood culture.
- Vasoconstrictor and volume dependent septic shock suspected to be caused by a Gram-negative agent and with positive plasma endotoxin test.
Exclusion Criteria:
- Infected with Hepatitis B or C or HIV.
- Dependence on dialysis treatment before the actual ICU episode.
Sites / Locations
- Perioperative and Intensive Care (Adult), Skåne University Hospital, Lund
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
oXiris
ST150
Arm Description
Continuous renal replacement therapy with filter that adsorbs cytokines/toxins.
Continuous renal replacement therapy with filter that does not adsorb cytokines/toxins.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
mean blood pressure
Additional parameter that describes the clinical impact from the septic state.
TNF-α level in blood
Additional parameter that describes the load from the septic shock.
IL-1β level in blood
Additional parameter that describes the load from the septic shock.
IL-6 level in blood
Additional parameter that describes the load from the septic shock.
IL-10
Additional parameter that describes the load from the septic shock.
Full Information
NCT ID
NCT02600312
First Posted
October 30, 2015
Last Updated
July 25, 2019
Sponsor
Skane University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02600312
Brief Title
Comparing Cytokines, Toxins Adsorbing oXiris Filter to ST150 Filter During CRRT in Patients With Septic Shock
Acronym
oXiris
Official Title
Comparing Cytokines, Toxins Adsorbing oXiris Filter to ST150 Filter During CRRT in Patients With Septic Shock
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
October 2015 (Actual)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
January 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Skane University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock, Acute Kidney Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
oXiris
Arm Type
Active Comparator
Arm Description
Continuous renal replacement therapy with filter that adsorbs cytokines/toxins.
Arm Title
ST150
Arm Type
No Intervention
Arm Description
Continuous renal replacement therapy with filter that does not adsorb cytokines/toxins.
Intervention Type
Device
Intervention Name(s)
oXiris
Intervention Description
oXiris CRRT filter which adsorbs cytokines, toxins.
Primary Outcome Measure Information:
Title
endotoxin level in blood
Description
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).
Time Frame
change from baseline to 48 hours
Secondary Outcome Measure Information:
Title
mean blood pressure
Description
Additional parameter that describes the clinical impact from the septic state.
Time Frame
hourly up to 48 hours
Title
TNF-α level in blood
Description
Additional parameter that describes the load from the septic shock.
Time Frame
change from baseline to 48 hours
Title
IL-1β level in blood
Description
Additional parameter that describes the load from the septic shock.
Time Frame
change from baseline to 48 hours
Title
IL-6 level in blood
Description
Additional parameter that describes the load from the septic shock.
Time Frame
change from baseline to 48 hours
Title
IL-10
Description
Additional parameter that describes the load from the septic shock.
Time Frame
change from baseline to 48 hours
Other Pre-specified Outcome Measures:
Title
level of vasoconstrictive infusion
Description
Need of vasoconstrictor because of shock, higher degree of shock means increased requirement of vasoconstrictor infusion.
Time Frame
hourly up to 48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Vasoconstrictor and volume dependent septic shock with known Gram-negative infectious agent in blood culture.
Vasoconstrictor and volume dependent septic shock suspected to be caused by a Gram-negative agent and with positive plasma endotoxin test.
Exclusion Criteria:
Infected with Hepatitis B or C or HIV.
Dependence on dialysis treatment before the actual ICU episode.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcus Broman, Associate professor
Organizational Affiliation
Dep Perioperative and Intensive Care, Skåne University Hospital, Lund, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Perioperative and Intensive Care (Adult), Skåne University Hospital, Lund
City
Lund
State/Province
Skåne
ZIP/Postal Code
22241
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
21893976
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.
Results Reference
result
PubMed Identifier
34519356
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.
Results Reference
derived
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Comparing Cytokines, Toxins Adsorbing oXiris Filter to ST150 Filter During CRRT in Patients With Septic Shock
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