Oxiris filter: how it removes cytokines and endotoxin in septic shock
Endotoxin and Cytokine Adsorption Properties of the Oxiris Hemofilter in Septic Shock: Evaluation of Saturation Phenomena and Inflammatory Mediators' Clearance Capacity
Pauls Stradins Clinical University Hospital · NCT07419802
This will test whether the Oxiris hemofilter keeps removing endotoxins and inflammatory proteins over 24 hours in adults with septic shock who need continuous kidney support.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 29 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Pauls Stradins Clinical University Hospital (other) |
| Locations | 1 site (Riga) |
| Trial ID | NCT07419802 on ClinicalTrials.gov |
What this trial studies
This is a prospective, single-center observational study of adult patients with septic shock receiving continuous veno-venous hemofiltration (CVVH) with the AN69-polyethylenimine (Oxiris) membrane. Investigators will measure endotoxin and cytokine levels in blood and effluent over a continuous 24-hour treatment period to quantify membrane adsorption capacity and look for signs of saturation. The study will also quantify cytokine clearance by convective transport and examine whether changes in adsorption correlate with clinical course and outcomes. Data will provide in vivo time-course information on how the Oxiris membrane performs in routine ICU use.
Who should consider this trial
Good fit: Adults (≥18 years) with septic shock by Sepsis-3 criteria who require CVVH with an Oxiris (AN69-polyethylenimine) membrane for at least 24 hours and meet the study's dynamic scoring inclusion range are eligible.
Not a fit: Patients under 18, pregnant patients, those with contraindications to citrate anticoagulation, those expected to die within 24 hours from irreversible conditions, or those not treated with Oxiris CVVH are unlikely to benefit from participating.
Why it matters
Potential benefit: If successful, the results could guide optimal timing for Oxiris filter replacement to maintain toxin removal and possibly improve care for patients with septic shock.
How similar studies have performed: Oxiris is widely used and has some supporting laboratory and clinical reports, but in vivo quantitative data on adsorption saturation over time are limited and not well characterized.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Riga
- Pauls Stradiņš Clinical University Hospital, Department of Anesthesiology and Reanimatology — Riga, Latvia (RECRUITING)
Study contacts
- Study coordinator: Darja Smirnova, MD
- Email: darja.smirnova@rsu.lv
- Phone: +37126359852
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Sepsis, Septic Shock, Blood Purification, Hemoadsorption, Oxiris, blood purification, hemoadsorption, septic shock