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

NCT07539883 | Recruiting

• 1 other identifier: B-2602-1024-103
• Study Type: observational
• Target: 360
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Septic Shock; Multiorgan Failure; Sepsis

Keywords

oXiris; Target Trial Emulation; Extracorporeal Blood Purification

Outcome Measures

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.

  From the initiation of CRRT (Time zero) until hospital discharge or death.

Secondary Outcomes (5)

• 3-day Cumulative Fluid Balance

  3 days after CRRT initiation.

• Time to Vasopressor Weaning

  From CRRT initiation through ICU discharge, up to 28 days

• Organ Dysfunction Improvement

  Baseline (Day 0) and Days 1, 2, 3, 7 of ICU stay.

• Changes in Inflammatory Markers

  Baseline (Day 0) and Days 1, 2, 3, 7 of ICU stay.

• Renal Recovery Status

  From CRRT initiation through hospital discharge, up to 90 days

Study Arms (2)

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.

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead
• Vantive Health LLC: collaborator

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

RECRUITING

Related Publications (4)

• Wang G, He Y, Guo Q, Zhao Y, He J, Chen Y, Chen W, Zhou Y, Peng Z, Deng K, Guan J, Xie W, Chang P, Liu Z. Continuous renal replacement therapy with the adsorptive oXiris filter may be associated with the lower 28-day mortality in sepsis: a systematic review and meta-analysis. Crit Care. 2023 Jul 9;27(1):275. doi: 10.1186/s13054-023-04555-x.

  PMID: 37424026 RESULT

• Zhang L, Srisawat N, Lee CC, Lee DH, Lee K, Liu Z, Mohamad Nor FS, Mustafar RB, Peerapornratana S, Pham HM, Sewa SDW, Tang GKY, Yeh YC, Zhu M, Yao Q, Wang M, Bellomo R. Extracorporeal Blood Purification with the oXiris(R) Filter for Patients with Sepsis and Hyperinflammatory Conditions: The Asia-Pacific oXiris Expert Meeting 2024 Consensus Statements. Blood Purif. 2025;54(11):621-638. doi: 10.1159/000548214. Epub 2025 Sep 10.

  PMID: 40929000 RESULT

• Ankawi G, Neri M, Zhang J, Breglia A, Ricci Z, Ronco C. Extracorporeal techniques for the treatment of critically ill patients with sepsis beyond conventional blood purification therapy: the promises and the pitfalls. Crit Care. 2018 Oct 25;22(1):262. doi: 10.1186/s13054-018-2181-z.

  PMID: 30360755 RESULT

• Chen J, Zhang Z, Gao J, Liu Y, Zhu B, Gao Y, Zhuang Y, Zhu M. A multicentre, randomised controlled clinical trial evaluating the effect of the adsorptive filter oXiris on haemodynamics in abdominal septic shock patients requiring continuous renal replacement therapy (Oxiris for Abdominal SEptic Shock study). BMJ Open. 2025 Jul 8;15(7):e094792. doi: 10.1136/bmjopen-2024-094792.

  PMID: 40633959 RESULT

MeSH Terms

Conditions

Shock, Septic; Multiple Organ Failure; Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Sung Yoon Lim, MD.PhD

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sung Yoon Lim, MD. PhD

CONTACT

82+1028469179; nucleon727@snu.ac.kr

Myung Jin Song, MD.PhD

CONTACT

82+1045990531; mjsong8705@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: March 25, 2026
• First Posted: April 20, 2026
• Study Start: January 22, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)