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OxiCLEAR (Oxiris Cytokines and Endotoxin Adsorption Rate) Study
Sponsor: Pauls Stradins Clinical University Hospital
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.
Official title: Endotoxin and Cytokine Adsorption Properties of the Oxiris Hemofilter in Septic Shock: Evaluation of Saturation Phenomena and Inflammatory Mediators' Clearance Capacity
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
29
Start Date
2026-03-01
Completion Date
2027-09-01
Last Updated
2026-02-19
Healthy Volunteers
No
Interventions
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.
Locations (1)
Pauls Stradiņš Clinical University Hospital, Department of Anesthesiology and Reanimatology
Riga, Latvia