Effect of oXiris Hemofilter Use in Septic Shock: A Multicenter Retrospective Cohort Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19+
SponsorSeoul National University Bundang Hospital
About this trial
This study aims to evaluate the clinical effectiveness of the oXiris® hemofilter in patients with septic shock and acute kidney injury (AKI) requiring continuous renal replacement therapy (CRRT). While some studies suggest that oXiris® may improve hemodynamic stability by removing endotoxins and cytokines, its impact on survival remains inconsistent.To provide more reliable causal evidence, this multicenter retrospective cohort study utilizes a Target Trial Emulation (TTE) approach. The study will compare patients treated with the oXiris® filter to those treated with standard CRRT filters, focusing on in-hospital mortality and other clinical outcomes such as fluid balance and vasopressor requirements.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 19 years or older.
Admitted to the ICU with septic shock (Sepsis-3 criteria) between March 2021 and August 2025.
Required Continuous Renal Replacement Therapy (CRRT) due to acute kidney injury (AKI).
Disqualifiers
Death or withdrawal of life-sustaining therapy within 48 hours of ICU admission.
Patients with End-Stage Renal Disease (ESRD).
Patients with missing critical covariates.
Trial population
The study population consists of adult patients (aged 19 or older) diagnosed with septic shock and acute kidney injury (AKI) who required continuous renal replacement therapy (CRRT). The treatment group includes approximately 120 patients who received the oXiris® hemofilter at five tertiary academic hospitals in South Korea between March 2021 and August 2025. The control group comprises approximately 240 patients who received standard CRRT filters, identified from the Korea Sepsis Alliance (KSA) registry, a nationwide multicenter sepsis cohort. All subjects are selected based on the availability of electronic medical records (EMR) and registry data that include critical clinical covariates for Target Trial Emulation.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
360 Participants
are grouped into 2 trial groupsGroup A: oXiris Group
Group B: Control Group (Standard CRRT)
Trial outcomes
Primary outcomes
1
In-hospital Mortality
The primary objective is to evaluate the causal effect of oXiris® hemofilter use on survival during the hospital stay compared to standard CRRT. Statistical analysis will be performed using an Inverse Probability of Treatment Weighting (IPTW)-weighted Cox proportional hazards model to adjust for baseline and time-varying confounders.
Time frame
From the initiation of CRRT (Time zero) until hospital discharge or death.Secondary outcomes
1
3-day Cumulative Fluid Balance
Comparison of the total fluid intake and output over the first 3 days after CRRT initiation.
Time frame
3 days after CRRT initiation.2
Time to Vasopressor Weaning
The duration from CRRT initiation until the successful discontinuation of all vasopressors.
Time frame
From CRRT initiation through ICU discharge, up to 28 days3
Organ Dysfunction Improvement
Evaluation of organ failure improvement through repeated measures of the Sequential Organ Failure Assessment (SOFA) score.
Time frame
Baseline (Day 0) and Days 1, 2, 3, 7 of ICU stay.4
Changes in Inflammatory Markers
Assessment of the reduction in serum levels of CRP, Procalcitonin, and lactate.
Time frame
Baseline (Day 0) and Days 1, 2, 3, 7 of ICU stay.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Seoul National University Bundang Hospital
Lead sponsor
Vantive Health LLC
Collaborator
Source ClinicalTrials.gov