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Completed

NCT Number: NCT02600312

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

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.

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Key information

Conditions

Septic Shock Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Inflammation Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Sepsis Shock Shock, Septic Systemic Inflammatory Response Syndrome Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Perioperative and Intensive Care (Adult), Skåne University Hospital, Lund

Lund, Skåne County, 22241, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oxiris

Device

oXiris CRRT filter which adsorbs cytokines, toxins.

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Skane University Hospital

Other

Registry information

Acronym: oXiris

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Nov 9, 2015
Registry last updated
Jul 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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