Clinical Trial

OxiCLEAR (Oxiris Cytokines and Endotoxin Adsorption Rate) Study

Study acronym: OxiCLEAR
Recruiting
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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.
Trial Details
NCT Number NCT07419802
Lead Sponsor Pauls Stradins Clinical University Hospital
Collaborators: Vantive Health LLC
Conditions Sepsis, Septic Shock, Blood Purification, Hemoadsorption
Enrollment 29 participants
Start Date 2026-03-01
Primary Completion 2027-09-01 (estimated)
Study Completion 2027-09-01 (estimated)
Updated on ClinicalTrials.gov 2026-02-19