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Endotoxin and Cytokine Adsorption Properties of the Oxiris Hemofilter in Septic Shock: Evaluation of Saturation Phenomena and Inflammatory Mediators' Clearance Capacity

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Septic shock patient with a Dynamic scoring system of 6-8 points /Septic shock definition based on Sepsis-3: a vasopressor requirement to maintain a mean arterial pressure of 65 mmHg or greater and serum lactate greater than 2mmol/L despite optimal (30ml/kg body weight) bolus fluid resuscitation/

• CVVH with AN69-polyethylenimine (Oxiris) membrane for at least 24 hours

• Age \>18 years

Locations
Other Locations
Latvia
Pauls Stradiņš Clinical University Hospital, Department of Anesthesiology and Reanimatology
RECRUITING
Riga
Contact Information
Primary
Darja Smirnova, MD
darja.smirnova@rsu.lv
+37126359852
Backup
Olegs Sabelnikovs, Prof
olegs.sabelnikovs@stradini.lv
+37129561827
Time Frame
Start Date: 2026-03-01
Estimated Completion Date: 2027-09-01
Participants
Target number of participants: 29
Treatments
Oxiris CVVH Septic Shock Cohort
Adult patients with septic shock admitted to the intensive care unit and treated with continuous veno-venous hemofiltration (CVVH) using the Oxiris® hemofilter as part of standard-of-care therapy. All participants receive the same CRRT modality; no comparator or control group is included. The cohort is used to evaluate time-dependent endotoxin and cytokine removal, membrane adsorption performance, and cytokine convective clearance during a 24-hour Oxiris® treatment period.
Related Therapeutic Areas
Sponsors
Leads: Pauls Stradins Clinical University Hospital
Collaborators: Vantive Health LLC

This content was sourced from clinicaltrials.gov