Actively Recruiting

Age: 18Years +
All Genders
NCT07419802

OxiCLEAR (Oxiris Cytokines and Endotoxin Adsorption Rate) Study

Led by Pauls Stradins Clinical University Hospital · Updated on 2026-02-19

29

Participants Needed

1

Research Sites

78 weeks

Total Duration

On this page

Sponsors

P

Pauls Stradins Clinical University Hospital

Lead Sponsor

V

Vantive Health LLC

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

OxiCLEAR (Oxiris Cytokines and Endotoxin Adsorption Rate) Study

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with septic shock meeting Sepsis-3 criteria, requiring vasopressors to keep mean arterial pressure 265 mmHg and serum lactate 3 2 mmol/L after fluid resuscitation
  • Dynamic scoring system of 6-8 points
  • Receiving continuous veno-venous hemofiltration (CVVH) with the Oxiris4 hemofilter for at least 24 hours
  • Age over 18 years
Not Eligible

You will not qualify if you...

  • Under 18 years of age
  • Pregnant
  • Known contraindications to citrate anticoagulation
  • High risk of death within 24 hours due to irreversible diseases like end-stage heart, lung, liver disease, hepatorenal syndrome, or advanced cancer
  • Receiving treatment with another adsorption device during the study period

AI-Screening

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Trial Site Locations

Total: 1 location

1

Pauls Stradiņš Clinical University Hospital, Department of Anesthesiology and Reanimatology

Riga, Latvia, LV1002

Actively Recruiting

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Research Team

D

Darja Smirnova, MD

CONTACT

O

Olegs Sabelnikovs, Prof

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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