NCT07419802 OxiCLEAR (Oxiris Cytokines and Endotoxin Adsorption Rate) Study
| NCT ID | NCT07419802 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Pauls Stradins Clinical University Hospital |
| Condition | Sepsis |
| Study Type | OBSERVATIONAL |
| Enrollment | 29 participants |
| Start Date | 2026-03-01 |
| Primary Completion | 2027-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 29 participants in total. It began in 2026-03-01 with a primary completion date of 2027-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria (should meet all the criteria mentioned below): * 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 Exclusion Criteria: * Age \< 18 years * Pregnancy * Known contraindications to citrate anticoagulation * High likelihood of death within 24 hours due to irreversible comorbidities (e.g., end-stage cardiac, pulmonary, or hepatic disease; hepatorenal syndrome; advanced uncontrolled malignancy) * Simultaneous treatment with another adsorption device during the study period
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07419802 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Sepsis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07419802 currently recruiting?
Yes, NCT07419802 is actively recruiting participants. Contact the research team at darja.smirnova@rsu.lv for enrollment information.
Where is the NCT07419802 trial being conducted?
This trial is being conducted at Riga, Latvia.
Who is sponsoring the NCT07419802 clinical trial?
NCT07419802 is sponsored by Pauls Stradins Clinical University Hospital. The trial plans to enroll 29 participants.