An observational study in Septic Shock, Multiorgan Failure and Sepsis, sponsored by Seoul National University Bundang Hospital. Recruiting at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-04-20.
Sponsored by Seoul National University Bundang Hospital · Observational
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.
Background:
Septic shock is characterized by a dysregulated host response to infection, leading to a "cytokine storm" that causes organ dysfunction and hemodynamic instability. Extracorporeal blood purification (EBP) using the oXiris® filter is designed to restore immune homeostasis by adsorbing both endotoxins and cytokines while performing standard CRRT functions. However, existing observational data often suffer from selection and immortal time biases.
Study Design and Methodology:
This study employs the Target Trial Emulation (TTE) framework to mimic the design of a randomized controlled trial using retrospective observational data.
Strategy A (oXiris): CRRT initiated with the oXiris® filter. Strategy B (Control): CRRT initiated with a standard filter, sourced from the Korea Sepsis Alliance registry.
To adjust for baseline confounding and confounding by indication, propensity score-based Inverse Probability of Treatment Weighting (IPTW) will be applied.
Primary Outcome: In-hospital mortality will be analyzed using an IPTW-weighted Cox proportional hazards model.
Secondary Outcomes:
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.
Exclusion Criteria:
Patients with septic shock and acute kidney injury (AKI) who initiated continuous renal replacement therapy (CRRT) using the oXiris® hemofilter at Time zero. Data for this cohort are collected from five tertiary medical centers in South Korea. The oXiris® filter is used for its combined functions of cytokine adsorption, endotoxin removal, and standard CRRT.
Patients with septic shock and AKI who initiated CRRT using a standard (non-adsorptive) hemofilter at Time zero. This cohort is identified and extracted from the Korea Sepsis Alliance (KSA) registry, a multicenter prospective sepsis cohort in South Korea. These patients receive standard-of-care CRRT without specific hemoadsorption properties.
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.
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.
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 days
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.
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.
Renal Recovery Status
Proportion of patients who recover renal function and do not require renal replacement therapy at the time of hospital discharge.
Time frame: From CRRT initiation through hospital discharge, up to 90 days
Plan to share: No — This is a retrospective study using electronic medical records and registry data. According to the institutional policy and data use agreements, individual participant data cannot be shared publicly to protect patient privacy.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Seoul National University Bundang Hospital