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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
Sponsor:
Information provided by (Responsible Party):
Marcus Broman, 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.


Condition or disease Intervention/treatment Phase
Septic Shock Acute Kidney Injury Device: oXiris Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arm Intervention/treatment
Active Comparator: oXiris
Continuous renal replacement therapy with filter that adsorbs cytokines/toxins.
Device: oXiris
oXiris CRRT filter which adsorbs cytokines, toxins.

No Intervention: ST150
Continuous renal replacement therapy with filter that does not adsorb cytokines/toxins.



Primary Outcome Measures :
  1. 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).



Secondary Outcome Measures :
  1. mean blood pressure [ Time Frame: hourly up to 48 hours ]
    Additional parameter that describes the clinical impact from the septic state.

  2. TNF-α level in blood [ Time Frame: change from baseline to 48 hours ]
    Additional parameter that describes the load from the septic shock.

  3. IL-1β level in blood [ Time Frame: change from baseline to 48 hours ]
    Additional parameter that describes the load from the septic shock.

  4. IL-6 level in blood [ Time Frame: change from baseline to 48 hours ]
    Additional parameter that describes the load from the septic shock.

  5. IL-10 [ Time Frame: change from baseline to 48 hours ]
    Additional parameter that describes the load from the septic shock.


Other Outcome Measures:
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Locations
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Sweden
Perioperative and Intensive Care (Adult), Skåne University Hospital, Lund
Lund, Skåne, Sweden, 22241
Sponsors and Collaborators
Skane University Hospital
Investigators
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Principal Investigator: Marcus Broman, Associate professor Dep Perioperative and Intensive Care, Skåne University Hospital, Lund, Sweden

Publications of Results:
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Responsible Party: Marcus Broman, M.D. Ph.D., Skane University Hospital
ClinicalTrials.gov Identifier: NCT02600312     History of Changes
Other Study ID Numbers: oXiris
First Posted: November 9, 2015    Key Record Dates
Last Update Posted: July 26, 2019
Last Verified: July 2019

Additional relevant MeSH terms:
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Shock
Acute Kidney Injury
Shock, Septic
Pathologic Processes
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation