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

NCT ID: NCT07334327

Last Updated: 2026-01-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-01
• Study Completion Date: 2027-12-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Oxiris Filter (Blood Purification Device)

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Oxiris hemofilter; AN69ST based filter

Eligibility Criteria

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.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vantive Health LLC

INDUSTRY

Sponsor Role: collaborator

Pusan National University Yangsan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Woo Hyun Cho

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Woohyun Cho, M.D., Ph.D

Role: CONTACT

popoyes@hanmail.net

82-55-360-4821

Other Identifiers

23-2025-005

Identifier Type: -

Identifier Source: org_study_id