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Evaluating the effectiveness of the oXiris blood filter in patients with severe infection (septic shock)

Evaluating the efficacy of continuous renal replacement therapy using the oXiris membrane on inflammatory mediator clearance in patients with septic shock.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12626001000392
Acronym
Xiris-SEPSIS
Enrollment
60
Registered
2026-08-14
Start date
2026-09-01
Completion date
2027-06-01
Last updated
2026-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Septic shock is a life-threatening condition where a severe infection causes dangerously low blood pressure and organ failure. To treat this, doctors often use continuous blood filtration machines (similar to dialysis). This study compares a highly specialized blood filter called 'oXiris' with a standard filter. The oXiris filter is uniquely designed to not only clean the blood but also trap and remove harmful bacterial toxins and inflammatory substances. The goal of this research is to see if using the oXiris filter helps patients stabilize faster, reduces their need for life-support medications, and improves their overall chances of survival compared to standard treatment.

Interventions

Patients in this intervention group will undergo Continuous Renal Replacement Therapy (CRRT) using the highly adsorptive oXiris membrane (Baxter). This membrane is designed to provide standard renal support while additionally removing cytokines and endotoxins from the bloodstream. The therapy will be initiated upon diagnosis of septic shock with an indication for CRRT. The oXiris filter will be routinely changed every 12 to 24 hours during the first 72 hours of treatment to maximize its adsorpti

Patients in this intervention group will undergo Continuous Renal Replacement Therapy (CRRT) using the highly adsorptive oXiris membrane (Baxter). This membrane is designed to provide standard renal support while additionally removing cytokines and endotoxins from the bloodstream. The therapy will be initiated upon diagnosis of septic shock with an indication for CRRT. The oXiris filter will be routinely changed every 12 to 24 hours during the first 72 hours of treatment to maximize its adsorptive capacity, or as dictated by clinical requirements such as circuit clotting or high transmembrane pressures. Adherence to the protocol will be monitored through daily clinical audits and electronic medical records, ensuring the filter changes and CRRT parameters are executed as specified. Any deviations from the treatment protocol will be documented in the patient’s Case Report Form (CRF).

Sponsors

Hanoi Medical University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Age 18 years or older. Diagnosed with septic shock according to the Sepsis-3 consensus definition. Sequential Organ Failure Assessment (SOFA) score >= 8. Requiring continuous vasopressor support (Noradrenaline dose >= 0.2 mcg/kg/min). Having a clinical indication for Continuous Renal Replacement Therapy (CRRT).

Exclusion criteria

Refusal to participate or lack of informed consent from the patient or their legally authorized representative. Imminent death or expected mortality within the first 24 hours of ICU admission. Patients currently receiving Extracorporeal Membrane Oxygenation (ECMO) support. Pregnant women.

Outcome results

None listed

Source: ANZCTR · Data processed: Aug 31, 2026