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OxiCLEAR (Oxiris Cytokines and Endotoxin Adsorption Rate) Study

NCT07419802 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 29

Last updated 2026-02-19

No results posted yet for this study

Summary

This study examines how well the Oxiris® hemofilter works over time in adults with septic shock who require continuous kidney support in the intensive care unit (ICU).

Septic shock is a severe form of infection that leads to organ failure, including acute kidney injury. Many people with septic shock require continuous renal replacement therapy (CRRT), a form of dialysis that runs continuously to support the kidneys. The Oxiris® hemofilter is a special type of CRRT filter designed not only to replace kidney function but also to remove harmful substances from the blood, including endotoxins from bacteria and inflammatory proteins (cytokines).

Although Oxiris® is widely used, it is not known how long the filter continues to remove these substances effectively. Over time, the membrane of the filter may become filled with endotoxins and cytokines, which could reduce its ability to clean the blood. This study aims to determine whether and when this loss of adsorption occurs during a standard twenty-four-hour treatment period.

Adults with septic shock who receive Oxiris® as part of routine ICU care will take part in this observational study. No experimental treatment will be given. Blood samples will be taken before and after the filter, and fluid leaving the filter will be collected, to measure how endotoxins and cytokines are removed over time.

The study will also assess how changes in filter performance relate to clinical markers such as blood pressure support, blood lactate levels, organ function scores, kidney recovery, and twenty-eight-day survival.

The results will help define the optimal timing for Oxiris® filter replacement and support more effective use of blood purification therapy in patients with septic shock.

Conditions

  • Sepsis
  • Septic Shock
  • Blood Purification
  • Hemoadsorption

Interventions

DEVICE

AN69-polyethylenimine hemofilter (Oxiris®) used for continuous veno-venous hemofiltration (CVVH)

Continuous veno-venous hemofiltration (CVVH) performed using the AN69-polyethylenimine (Oxiris®) hemofilter as part of standard-of-care treatment in adult patients with septic shock. The Oxiris® membrane is a high-adsorptive, polyethyleneimine-coated AN69 filter designed for simultaneous renal replacement therapy and removal of circulating endotoxins and inflammatory mediators. CVVH is delivered using standardized clinical settings, including blood flow 100-150 mL/min, filtration dose 25-30 mL/kg/h, regional citrate anticoagulation, and a 24-hour treatment period with serial blood and effluent sampling to assess membrane adsorption and convective clearance.

Sponsors & Collaborators

  • Vantive Health LLC

    collaborator INDUSTRY

  • Pauls Stradins Clinical University Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2027-09-01
Completion
2027-09-01

Countries

  • Latvia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07419802 on ClinicalTrials.gov