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

Pusan National University Yangsan Hospital

Status: Not yet enrolling

Conditions: Multi Organ Failure; Septic Shock

Treatments: Device: Oxiris Filter (Blood Purification Device)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07334327

23-2025-005

Details and patient eligibility

About

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.

Enrollment: 62 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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62 participants in 1 patient group

Oxiris Treatment Group

Experimental group

Description:

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.

Treatment:

Device: Oxiris Filter (Blood Purification Device)