Effect of oXiris Hemofilter Use in Septic Shock: A Multicenter Retrospective Cohort Study

April 13, 2026 updated by: LIM SUNG YOON, Seoul National University Bundang Hospital

Official Title: Effect of oXiris Hemofilter Use in Septic Shock: A Multicenter Retrospective Cohort Study Using a Target Trial Emulation Approach

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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

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.

  • Target Population: Adult patients (≥19 years) admitted to the ICU with septic shock and AKI requiring CRRT between March 2021 and August 2025.
  • Time Zero: Defined as the initiation of CRRT.
  • Treatment Strategies:

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.

  • Data Sources: Data will be collected from five major medical centers in South Korea: Seoul National University Bundang Hospital, Hallym University Sacred Heart Hospital, Chung-Ang University Hospital, Samsung Medical Center, and Asan Medical Center.
  • Statistical Analysis Plan:

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:

  • Fluid Balance: 3-day cumulative fluid balance using landmark analysis and IPTW-weighted linear regression.
  • Vasopressor Weaning: Analyzed using a weighted Fine-Gray risk model, considering death as a competing risk.
  • Organ Function & Inflammation: Repeated measures of SOFA scores and inflammatory markers (CRP, Procalcitonin, lactate) using IPTW-weighted linear mixed-effects models.
  • Renal Recovery: Evaluated via IPTW-weighted logistic regression.

Study Type

Observational

Enrollment (Estimated)

360

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • South Korea
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, South Korea, 13620
        • Recruiting
        • Seoul National University Bundang Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study 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.

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
oXiris Group
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.
Control Group (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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
In-hospital Mortality
Time Frame: From the initiation of CRRT (Time zero) until hospital discharge or death.
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.
From the initiation of CRRT (Time zero) until hospital discharge or death.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3-day Cumulative Fluid Balance
Time Frame: 3 days after CRRT initiation.
Comparison of the total fluid intake and output over the first 3 days after CRRT initiation.
3 days after CRRT initiation.
Time to Vasopressor Weaning
Time Frame: From CRRT initiation through ICU discharge, up to 28 days
The duration from CRRT initiation until the successful discontinuation of all vasopressors.
From CRRT initiation through ICU discharge, up to 28 days
Organ Dysfunction Improvement
Time Frame: Baseline (Day 0) and Days 1, 2, 3, 7 of ICU stay.
Evaluation of organ failure improvement through repeated measures of the Sequential Organ Failure Assessment (SOFA) score.
Baseline (Day 0) and Days 1, 2, 3, 7 of ICU stay.
Changes in Inflammatory Markers
Time Frame: Baseline (Day 0) and Days 1, 2, 3, 7 of ICU stay.
Assessment of the reduction in serum levels of CRP, Procalcitonin, and lactate.
Baseline (Day 0) and Days 1, 2, 3, 7 of ICU stay.
Renal Recovery Status
Time Frame: From CRRT initiation through hospital discharge, up to 90 days
Proportion of patients who recover renal function and do not require renal replacement therapy at the time of hospital discharge.
From CRRT initiation through hospital discharge, up to 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang Hospital

Collaborators

Vantive Health LLC

Investigators

  • Principal Investigator: Sung Yoon Lim, MD.PhD, Seoul National University Bundang Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 22, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

March 25, 2026

First Submitted That Met QC Criteria

April 13, 2026

First Posted (Actual)

April 20, 2026

Study Record Updates

Last Update Posted (Actual)

April 20, 2026

Last Update Submitted That Met QC Criteria

April 13, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B-2602-1024-103

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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