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

NCT02600312 | Completed

• 1 other identifier: oXiris
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Septic Shock; Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• mean blood pressure

  hourly up to 48 hours

• TNF-α level in blood

  change from baseline to 48 hours

• IL-1β level in blood

  change from baseline to 48 hours

• IL-6 level in blood

  change from baseline to 48 hours

• IL-10

  change from baseline to 48 hours

Other Outcomes (1)

• level of vasoconstrictive infusion

  hourly up to 48 hours

Study Arms (2)

oXiris

ACTIVE COMPARATOR

Continuous renal replacement therapy with filter that adsorbs cytokines/toxins.

Device: oXiris

ST150

NO INTERVENTION

Continuous renal replacement therapy with filter that does not adsorb cytokines/toxins.

Interventions

oXiris DEVICE

oXiris CRRT filter which adsorbs cytokines, toxins.

oXiris

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Infected with Hepatitis B or C or HIV.
• Dependence on dialysis treatment before the actual ICU episode.

Sponsors & Collaborators

• Skane University Hospital: lead

Study Sites (1)

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

Lund, Skåne County, 22241, Sweden

Location

Related Publications (2)

• 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.

  PMID: 21893976 RESULT

• 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.

  PMID: 34519356 DERIVED

MeSH Terms

Conditions

Shock, Septic; Acute Kidney Injury

Condition Hierarchy (Ancestors)

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

Study Officials

• Marcus Broman, Associate professor

  Dep Perioperative and Intensive Care, Skåne University Hospital, Lund, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D. Ph.D.

Study Record Dates

• First Submitted: October 30, 2015
• First Posted: November 9, 2015
• Study Start: October 1, 2015
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: July 26, 2019

Record last verified: 2019-07

Locations

SE (1)