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Trials / Not Yet Recruiting

Not Yet RecruitingNCT07334327

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

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

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
62 (estimated)
Sponsor
Pusan National University Yangsan Hospital · Academic / Other
Sex
All
Age
19 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DEVICEOxiris 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.

Timeline

Start date
2026-02-01
Primary completion
2027-12-31
Completion
2027-12-31
First posted
2026-01-12
Last updated
2026-01-14

Source: ClinicalTrials.gov record NCT07334327. Inclusion in this directory is not an endorsement.