Extracorporeal Blood Purification Using Oxiris for Septic Shock (EXPLORE Study)
NCT07334327 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 62
Last updated 2026-01-14
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 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.
Conditions
- Septic Shock
- Multi Organ Failure
Interventions
- 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.
Sponsors & Collaborators
-
Vantive Health LLC
collaborator INDUSTRY -
Pusan National University Yangsan Hospital
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 19 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-02-01
- Primary Completion
- 2027-12-31
- Completion
- 2027-12-31
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