Extracorporeal Blood Purification Using Oxiris for Septic Shock (EXPLORE Study)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Oxiris Filter (Blood Purification Device).
- Who it may be relevant to
- Registry conditions: Septic Shock, Multi Organ Failure. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy of eXtracorPoreal bLOod puRification Using oXiris in Patients With SEptic Shock: A Multicenter Propensity-matched Cohort Study (EXPOLRE Study)
Overview
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.
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
Primary outcome measures
- Composite of early organ dysfunction and mortality at Day 7 [Time frame: 7 days after treatment initiation]
Secondary outcome measures (4)
- All-cause mortality [Time frame: Day 28]
- Change in Sequential Organ Failure Assessment(SOFA) score [Time frame: Day 3]
- Change in Procalcitonin [Time frame: Day 3]
- Change in IL-6 [Time frame: Day 3]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07334327 · 23-2025-005