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NCT Number: NCT07334327

Extracorporeal Blood Purification Using Oxiris for Septic Shock (EXPLORE 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.

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Key information

Conditions

Septic Shock Infections Inflammation Multi Organ Failure Multiple Organ Failure Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oxiris Filter (Blood Purification Device)

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. All-cause mortality

    Time frame: Day 28

    Percentage of participants who died from any cause

  2. Change in Sequential Organ Failure Assessment(SOFA) score

    Time frame: Day 3

    Change in the Sequential Organ Failure Assessment (SOFA) score from baseline to Day 3 (Higher scores mean a worse outcome)

  3. Change in Procalcitonin

    Time frame: Day 3

    Change in serum procalcitonin levels as an inflammatory marker

  4. Change in IL-6

    Time frame: Day 3

    Change in Interleukin-6 levels (if measured).

Study contacts

Contact information is provided by the study sponsor or research team.

Woohyun Cho, M.D., Ph.D

CONTACT

[email protected]

82-55-360-4821

Sponsors and collaborators

Lead sponsor

Pusan National University Yangsan Hospital

Other

Collaborators

  • Vantive Health LLC

Registry information

Official study title

Efficacy of eXtracorPoreal bLOod puRification Using oXiris in Patients With SEptic Shock: A Multicenter Propensity-matched Cohort Study (EXPOLRE Study)

Acronym: EXPOLRE

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 12, 2026
Registry last updated
Jan 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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