Septic ShockNCT07539883
Effect of oXiris Hemofilter Use in Septic Shock: A Multicenter Retrospective Cohort Study
An observational study of Septic Shock and Multiorgan Failure, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial 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). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Septic Shock, Multiorgan Failure, Sepsis
- How many people
- 360 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Jan 2026to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
Sung Yoon Lim, MD PhD, 82+1028469179, nucleon727@snu.ac.kr
Myung Jin Song, MD.PhD, 82+1045990531, mjsong8705@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Septic Shock, Multiorgan Failure, Sepsis
- Keywords
- oXiris, Target Trial Emulation, Extracorporeal Blood Purification
- Medical subject headings
- Shock, Septic, Multiple Organ Failure, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the initiation of CRRT (Time zero) until hospital discharge or death.
Secondary outcomes (5)
3-day Cumulative Fluid Balance
Comparison of the total fluid intake and output over the first 3 days after CRRT initiation.
Measured: 3 days after CRRT initiation.
Time to Vasopressor Weaning
The duration from CRRT initiation until the successful discontinuation of all vasopressors.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From CRRT initiation through hospital discharge, up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start22 Jan 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Vantive Health LLC
- Responsible party
- Principal investigator, LIM SUNG YOON, Seoul National University Bundang Hospital
- Investigators
- Sung Yoon Lim, MD.PhD, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07539883
- Sponsor's protocol ID
- B-2602-1024-103
- Status last verified
- Mar 2026
- First submitted
- 25 Mar 2026
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 37424026Zhang 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.
PubMed 40929000Ankawi 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.
PubMed 30360755Chen 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.
PubMed 40633959
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Official Title: Effect of oXiris Hemofilter Use in Septic Shock: A Multicenter Retrospective Cohort Study Using a Target Trial Emulation Approach
- ClinicalTrials.gov ID
- NCT07539883
- Acronym / sponsor ID
- B-2602-1024-103
- Conditions
- Septic Shock, Multiorgan Failure, Sepsis
- Keywords
- oXiris, Target Trial Emulation, Extracorporeal Blood Purification
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Collaborators
- Vantive Health LLC
- Study start
- 22 Jan 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
5 secondary outcomes
3-day Cumulative Fluid Balance
Time frame: 3 days after CRRT initiation.
Time to Vasopressor Weaning
Time frame: 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.
Changes in Inflammatory Markers
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Results publication: PubMed 37424026Wang 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.
- Results publication: PubMed 40929000Zhang 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.
- Results publication: PubMed 30360755Ankawi 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.
- Results publication: PubMed 40633959Chen 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sung Yoon Lim, MD.PhD principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Septic Shock and Multiorgan Failure, run by Seoul National University Bundang Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sung Yoon Lim, MD. PhD (82+1028469179, nucleon727@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-hospital Mortality (time frame: From the initiation of CRRT (Time zero) until hospital discharge or death.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07539883, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.