Septic ShockEXPOLRENCT07334327
Extracorporeal Blood Purification Using Oxiris for Septic Shock (EXPLORE Study)
A study testing Oxiris Filter (Blood Purification Device) in people with Septic Shock and Multi Organ Failure, run by Pusan National University Yangsan Hospital.
Trial summary
The goal of this clinical trial is to evaluate if a blood purification treatment called "Oxiris" works to help adults with septic shock. The main questions it aims to answer are: (1) Does Oxiris treatment lower the risk of death or organ failure within the first 7 days? (2) Does Oxiris treatment lower the level of… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Septic Shock, Multi Organ Failure
- What is being tested?
- Oxiris Filter (Blood Purification Device)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2026to 31 Dec 2027
- Phase
- Interventional
- 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
Who may be able to join
- Participants must be 19 years of age or older.
- Participants must be diagnosed with septic shock (a severe body-wide response to infection that leads to dangerously low blood pressure).
- Participants must be in a condition where the medical team has decided that blood purification therapy (like CRRT) is necessary.
Who cannot join
- People who have a "Do Not Resuscitate" (DNR) order or are not expected to survive more than 24 hours.
- People who are pregnant or breastfeeding.
- People who are known to be allergic to the materials used in the Oxiris filter (such as heparin or specific plastics).
- People who are already participating in another clinical trial that might affect the results of this study.
- People whom the doctor decides are not suitable for the study for other medical safety reasons.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy of eXtracorPoreal bLOod puRification Using oXiris in Patients With SEptic Shock: A Multicenter Propensity-matched Cohort Study (EXPOLRE Study)
The goal of this clinical trial is to evaluate if a blood purification treatment called "Oxiris" works to help adults with septic shock. The main questions it aims to answer are: (1) Does Oxiris treatment lower the risk of death or organ failure within the first 7 days? (2) Does Oxiris treatment lower the level of inflammation in the body? Researchers will compare participants who receive Oxiris treatment to a group of participants who receive standard medical care to see if Oxiris helps them recover better.
Participants will:
- Receive blood purification therapy using the Oxiris filter for up to 3 days while in the intensive care unit (ICU).
- Have their blood tested at the start of the study and 3 days later to check for inflammation and organ function.
- Be followed by the research team for about 30 days to check on their health and recovery.
- Conditions
- Septic Shock, Multi Organ Failure
- Being tested
- Oxiris Filter (Blood Purification Device)
- Keywords
- Septic shock, multi organ failure, blood purification, cytokine
- Medical subject headings
- Shock, Septic, Multiple Organ Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxiris Filter (Blood Purification Device)Device
Also called Oxiris hemofilter, AN69ST based filter
The Oxiris filter (Baxter) will be used for extracorporeal blood purification in patients with septic shock.
- Standard Procedure: All participants will undergo continuous venovenous hemodiafiltration (CVVHDF) or slow continuous ultrafiltration (SCUF) depending on the need for renal replacement therapy (RRT).
- Oxiris Protocol: To maximize the adsorption efficacy of endotoxins and cytokines, the Oxiris filter will be replaced every 24 hours.
- Duration: The treatment will continue for up to 72 hours (total of 3 filters per participant).
- Control Comparison: The outcomes of this intervention group will be compared with a propensity score-matched control group from the Korean Sepsis Alliance (KSA) registry who received standard care without Oxiris.
| Study group | Role | What they receive |
|---|---|---|
| Oxiris Treatment Group | Experimental | Participants in this arm will receive extracorporeal blood purification therapy using the Oxiris filter (Baxter) for the management of septic shock. The intervention consists of continuous venovenous hemodiafiltration (CVVHDF) for up to 72 hours, with the Oxiris filter replaced every 24 hours to maximize adsorption efficacy. For patients not requiring renal replacement therapy (RRT), slow continuous ultrafiltration (SCUF) will be performed for adsorption therapy only. All participants will also receive standard intensive care according to institutional protocols. Receives: Device: Oxiris Filter (Blood Purification Device) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of early organ dysfunction and mortality at Day 7
This is a composite outcome defined as either an increase in Sequential Organ Failure Assessment (SOFA) score of 2 points or more from baseline, or death from any cause, within 7 days after the start of Oxiris treatment. The SOFA score measures the function of six organ systems (respiratory, cardiovascular, hepatic, coagulation, renal, and neurological), with higher scores indicating more severe organ dysfunction.
Measured: 7 days after treatment initiation
Secondary outcomes (4)
All-cause mortality
Percentage of participants who died from any cause
Measured: Day 28
Change in Sequential Organ Failure Assessment(SOFA) score
Change in the Sequential Organ Failure Assessment (SOFA) score from baseline to Day 3 (Higher scores mean a worse outcome)
Measured: Day 3
Change in Procalcitonin
Change in serum procalcitonin levels as an inflammatory marker
Measured: Day 3
Change in IL-6
Change in Interleukin-6 levels (if measured).
Measured: Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start1 Feb 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a multicenter, single-arm interventional study designed to evaluate the efficacy of Oxiris-based blood purification therapy in patients with septic shock. To evaluate the treatment effect, the study will use an external control group from the Korean Sepsis Alliance (KSA) registry, a large-scale prospective observational cohort. Researchers will apply 1:2 propensity score matching based on age, sex, comorbidities, initial SOFA score, and site of infection to compare the Oxiris-treated group with the control group.
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pusan National University Yangsan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Vantive Health LLC
- Responsible party
- Principal investigator, Woo Hyun Cho, Pusan National University Yangsan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07334327
- Sponsor's protocol ID
- 23-2025-005
- Acronym
- EXPOLRE
- Status last verified
- Jan 2026
- First submitted
- 31 Dec 2025
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared to protect the privacy of study participants. The data contains sensitive clinical information, and the current IRB approval and informed consent do not include provisions for public data sharing with external researchers.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of eXtracorPoreal bLOod puRification Using oXiris in Patients With SEptic Shock: A Multicenter Propensity-matched Cohort Study (EXPOLRE Study)
- ClinicalTrials.gov ID
- NCT07334327
- Acronym / sponsor ID
- EXPOLRE / 23-2025-005
- Conditions
- Septic Shock, Multi Organ Failure
- Keywords
- Septic shock, multi organ failure, blood purification, cytokine
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Pusan National University Yangsan HospitalUniversity, hospital or other
- Collaborators
- Vantive Health LLC
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 12 Jan 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.
The goal of this clinical trial is to evaluate if a blood purification treatment called "Oxiris" works to help adults with septic shock. The main questions it aims to answer are: (1) Does Oxiris treatment lower the risk of death or organ failure within the first 7 days? (2) Does Oxiris treatment lower the level of inflammation in the body? Researchers will compare participants who receive Oxiris treatment to a group of participants who receive standard medical care to see if Oxiris helps them recover better.
Participants will:
- Receive blood purification therapy using the Oxiris filter for up to 3 days while in the intensive care unit (ICU).
- Have their blood tested at the start of the study and 3 days later to check for inflammation and organ function.
- Be followed by the research team for about 30 days to check on their health and recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a multicenter, single-arm interventional study designed to evaluate the efficacy of Oxiris-based blood purification therapy in patients with septic shock. To evaluate the treatment effect, the study will use an external control group from the Korean Sepsis Alliance (KSA) registry, a large-scale prospective observational cohort. Researchers will apply 1:2 propensity score matching based on age, sex, comorbidities, initial SOFA score, and site of infection to compare the Oxiris-treated group with the control group.
| Arm | Type | Receives |
|---|---|---|
| Oxiris Treatment Group | Experimental | Device: Oxiris Filter (Blood Purification Device)Participants in this arm will receive extracorporeal blood purification therapy using the Oxiris filter (Baxter) for the management of septic shock. The intervention consists of continuous venovenous hemodiafiltration (CVVHDF) for up to 72 hours, with the Oxiris filter replaced every 24 hours to maximize adsorption efficacy. For patients not requiring renal replacement therapy (RRT), slow continuous ultrafiltration (SCUF) will be performed for adsorption therapy only. All participants will also receive standard intensive care according to institutional protocols. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants must be 19 years of age or older.
- Participants must be diagnosed with septic shock (a severe body-wide response to infection that leads to dangerously low blood pressure).
- Participants must be in a condition where the medical team has decided that blood purification therapy (like CRRT) is necessary.
Key exclusion criteria (5 listed)
- People who have a "Do Not Resuscitate" (DNR) order or are not expected to survive more than 24 hours.
- People who are pregnant or breastfeeding.
- People who are known to be allergic to the materials used in the Oxiris filter (such as heparin or specific plastics).
- People who are already participating in another clinical trial that might affect the results of this study.
- People whom the doctor decides are not suitable for the study for other medical safety reasons.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxiris Filter (Blood Purification Device)Also: Oxiris hemofilter, AN69ST based filterThe Oxiris filter (Baxter) will be used for extracorporeal blood purification in patients with septic shock. * Standard Procedure: All participants will undergo continuous venovenous hemodiafiltration (CVVHDF) or slow continuous ultrafiltration (SCUF) depending on the need for renal replacement therapy (RRT). * Oxiris Protocol: To maximize the adsorption efficacy of endotoxins and cytokines, the Oxiris filter will be replaced every 24 hours. * Duration: The treatment will continue for up to 72 hours (total of 3 filters per participant). * Control Comparison: The outcomes of this intervention group will be compared with a propensity score-matched control group from the Korean Sepsis Alliance (KSA) registry who received standard care without Oxiris. | Device | Oxiris Treatment Group |
Primary outcome
Composite of early organ dysfunction and mortality at Day 7
Time frame: 7 days after treatment initiation
This is a composite outcome defined as either an increase in Sequential Organ Failure Assessment (SOFA) score of 2 points or more from baseline, or death from any cause, within 7 days after the start of Oxiris treatment. The SOFA score measures the function of six organ systems (respiratory, cardiovascular, hepatic, coagulation, renal, and neurological), with higher scores indicating more severe organ dysfunction.
4 secondary outcomes
All-cause mortality
Time frame: Day 28
Change in Sequential Organ Failure Assessment(SOFA) score
Time frame: Day 3
Change in Procalcitonin
Time frame: Day 3
Change in IL-6
Time frame: Day 3
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 14 Jan 2026.
- Individual participant dataSharing planned: No. IPD will not be shared to protect the privacy of study participants. The data contains sensitive clinical information, and the current IRB approval and informed consent do not include provisions for public data sharing with external researchers.
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A Trial of Adjunctive Fludrocortisone (50mcg, 100mcg or Placebo) in Critically Ill Patients With Septic Shock Receiving Hydrocortisone, Evaluating Survival and Functional Recovery and the Influence of Transcriptomic Response
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Oxiris Filter (Blood Purification Device) in people with Septic Shock and Multi Organ Failure, run by Pusan National University Yangsan Hospital.
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 5 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: opening soon, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Woohyun Cho, M.D., Ph.D (82-55-360-4821, popoyes@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of early organ dysfunction and mortality at Day 7 (time frame: 7 days after treatment initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jan 2026.