OxiCLEAR (Oxiris Cytokines and Endotoxin Adsorption Rate) Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorPauls Stradins Clinical University Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
AN69-polyethylenimine hemofilter (Oxiris®) used for continuous veno-venous hemofiltration (CVVH)
DeviceContinuous 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.
Treatment groups
29 Participants
are divided into 1 treatment groupGroup A: Oxiris CVVH Septic Shock Cohort1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline, and 1, 3, 6, 12 and 24 hours after initiation of CVVH with Oxiris®.2
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.
Time frame
Baseline and 1, 3, 6, 12 and 24 hours after initiation of CVVH with Oxiris®.Secondary outcomes
1
Hemodynamic changes associated with membrane adsorption performance
Changes in vasopressor requirements in relation to Oxiris® membrane adsorption performance during 24 hours of treatment
Time frame
Baseline and 24 hours after initiation of CVVH with Oxiris®2
Lactate changes associated with membrane adsorption performance
Changes in serum lactate in relation to Oxiris® adsorption performance during 24 hours of treatment
Time frame
Baseline and 24 hours after initiation of CVVH with Oxiris®3
Changes in Sequential Organ Failure Assessment score in relation to Oxiris® adsorption performance at 24 hours
Changes in Sequential Organ Failure Assessment score in relation to Oxiris® adsorption performance at 24 hours. With a minimum score of 0 points and a maximum of 24 points, higher scores indicate worse outcomes.
Time frame
Baseline and 24 hours after initiation of CVVH with Oxiris®4
Inflammatory marker (C-reactive protein) response associated with membrane adsorption performance
Changes in C-reactive protein concentration in relation to Oxiris® adsorption performance during 24 hours of treatment
Time frame
Baseline and 24 hours after initiation of CVVH with Oxiris®Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Pauls Stradins Clinical University Hospital
Lead sponsor
Vantive Health LLC
Collaborator
Source ClinicalTrials.gov