Extracorporeal Blood Purification Using Oxiris for Septic Shock (EXPLORE Study) (EXPOLRE)

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:

1. Receive blood purification therapy using the Oxiris filter for up to 3 days while in the intensive care unit (ICU).
2. Have their blood tested at the start of the study and 3 days later to check for inflammation and organ function.
3. Be followed by the research team for about 30 days to check on their health and recovery.

Study Overview

• Status: Not yet recruiting
• Conditions: Septic Shock; Multi Organ Failure
• Intervention / Treatment: Device: Oxiris Filter (Blood Purification Device)

• Study Type: Interventional
• Enrollment (Estimated): 62
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Woohyun Cho, M.D., Ph.D; Phone Number: 82-55-360-4821; Email: popoyes@hanmail.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Oxiris Treatment Group; 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.

Device: Oxiris Filter (Blood Purification Device); 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.; Other Names: Oxiris hemofilter; AN69ST based filter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	7 days after treatment initiation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality	Percentage of participants who died from any cause	Day 28
Change in Procalcitonin	Change in serum procalcitonin levels as an inflammatory marker	Day 3
Change in IL-6	Change in Interleukin-6 levels (if measured).	Day 3
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)	Day 3

Collaborators and Investigators

• Sponsor: Pusan National University Yangsan Hospital
• Collaborators: Vantive Health LLC

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: December 31, 2025
• First Submitted That Met QC Criteria: December 31, 2025
• First Posted (Estimated): January 12, 2026

Study Record Updates

• Last Update Posted (Actual): January 14, 2026
• Last Update Submitted That Met QC Criteria: January 12, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Septic shock; cytokine; multi organ failure; blood purification
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Shock; Pathological Conditions, Signs and Symptoms; Shock, Septic; Multiple Organ Failure
• Other Study ID Numbers: 23-2025-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No