OxiCLEAR (Oxiris Cytokines and Endotoxin Adsorption Rate) Study

NCT07419802 | Recruiting

• 1 other identifier: 2-PĒK-4/429/2022
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis; Septic Shock; Blood Purification; Hemoadsorption

Keywords

Oxiris; blood purification; hemoadsorption; septic shock; saturation phenomena; Continuous renal replacement therapy (CRRT); AN69-polyethylenimine membrane; Endotoxin adsorption; Cytokine adsorption; Membrane saturation; Mass balance; Inlet-outlet concentration gradient; Membrane fouling; Precision blood purification; Endotoxemia

Outcome Measures

Primary Outcomes (2)

• Endotoxin adsorptive capacity of the Oxiris® membrane

  Endotoxin adsorption rate calculated from the difference between inlet (C\_in) and outlet (C\_out) endotoxin concentrations multiplied by plasma flow (Qp) and normalized to membrane surface area (U/cm²/min), reflecting true membrane adsorption.

  Baseline, and 1, 3, 6, 12 and 24 hours after initiation of CVVH with Oxiris®.

• Cytokine adsorptive capacity and cytokine clearance over time

  Cytokine removal quantified by (i) total plasma clearance (from C\_in and C\_out), (ii) convective clearance (from effluent concentration × effluent flow), and (iii) adsorptive clearance (plasma clearance minus convective clearance), normalized to membrane surface area.

  Baseline and 1, 3, 6, 12 and 24 hours after initiation of CVVH with Oxiris®.

Secondary Outcomes (7)

• Hemodynamic changes associated with membrane adsorption performance

  Baseline and 24 hours after initiation of CVVH with Oxiris®

• Lactate changes associated with membrane adsorption performance

  Baseline and 24 hours after initiation of CVVH with Oxiris®

• Changes in Sequential Organ Failure Assessment score in relation to Oxiris® adsorption performance at 24 hours

  Baseline and 24 hours after initiation of CVVH with Oxiris®

• Inflammatory marker (C-reactive protein) response associated with membrane adsorption performance

  Baseline and 24 hours after initiation of CVVH with Oxiris®

• Inflammatory markers (Procalcitonin) response associated with membrane adsorption performance

  Baseline and 24 hours after initiation of CVVH with Oxiris®

Study Arms (1)

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.

Device: AN69-polyethylenimine hemofilter (Oxiris®) used for continuous veno-venous hemofiltration (CVVH)

Interventions

AN69-polyethylenimine hemofilter (Oxiris®) used for continuous veno-venous hemofiltration (CVVH) DEVICE

Continuous veno-venous hemofiltration (CVVH) performed using the AN69-polyethylenimine (Oxiris®) hemofilter as part of standard-of-care treatment in adult patients with septic shock. The Oxiris® membrane is a high-adsorptive, polyethyleneimine-coated AN69 filter designed for simultaneous renal replacement therapy and removal of circulating endotoxins and inflammatory mediators. CVVH is delivered using standardized clinical settings, including blood flow 100-150 mL/min, filtration dose 25-30 mL/kg/h, regional citrate anticoagulation, and a 24-hour treatment period with serial blood and effluent sampling to assess membrane adsorption and convective clearance.

Oxiris CVVH Septic Shock Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include adult patients (≥18 years of age) of any gender who are diagnosed with septic shock and admitted to the intensive care unit (ICU). All enrolled patients must receive continuous veno-venous hemofiltration (CVVH) with a high-adsorptive AN69-polyethyleneimine membrane (Oxiris®) for a minimum duration of 24 hours as part of their clinical management.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pauls Stradins Clinical University Hospital: lead
• Vantive Health LLC: collaborator

Study Sites (1)

Pauls Stradiņš Clinical University Hospital, Department of Anesthesiology and Reanimatology

Riga, LV1002, Latvia

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood and effluent samples will be collected from each patient before Oxiris® CVVH initiation (T0) and at 1h, 3h, 6h, 12h, and 24h pre- and post-filter to measure endotoxin and inflammatory mediator concentrations, assess membrane time to saturation and clearance rates, and evaluate systemic response. Blood samples will also be analyzed for complete blood count (hemoglobin, leukocytes, platelets), coagulation markers, inflammatory markers (PCT, CRP, IL-6), and kidney and liver function biomarkers. Samples will be retained for research purposes only, following standard preservation protocols, with anonymization to protect patient confidentiality.

MeSH Terms

Conditions

Sepsis; Shock, Septic; Endotoxemia

Interventions

Continuous Renal Replacement Therapy

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Bacteremia; Toxemia

Intervention Hierarchy (Ancestors)

Renal Replacement Therapy; Therapeutics; Extracorporeal Circulation; Surgical Procedures, Operative

Central Study Contacts

Darja Smirnova, MD

CONTACT

+37126359852; darja.smirnova@rsu.lv

Olegs Sabelnikovs, Prof

CONTACT

+37129561827; olegs.sabelnikovs@stradini.lv

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2026
• First Posted: February 19, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: February 19, 2026

Record last verified: 2026-02

Locations

LA (1)