Extracorporeal Blood Purification Using Oxiris for Septic Shock (EXPLORE Study)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorPusan National University Yangsan Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Oxiris Filter (Blood Purification Device)
DeviceThe 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.
Treatment groups
62 Participants
are divided into 1 treatment groupGroup A: Oxiris Treatment GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Composite of early organ dysfunction and mortality at Day 7
This is a composite outcome defined as either an increase in Sequential Organ Failure Assessment (SOFA) score of 2 points or more from baseline, or death from any cause, within 7 days after the start of Oxiris treatment. The SOFA score measures the function of six organ systems (respiratory, cardiovascular, hepatic, coagulation, renal, and neurological), with higher scores indicating more severe organ dysfunction.
Time frame
7 days after treatment initiationSecondary outcomes
1
All-cause mortality
Percentage of participants who died from any cause
Time frame
Day 282
Change in Sequential Organ Failure Assessment(SOFA) score
Change in the Sequential Organ Failure Assessment (SOFA) score from baseline to Day 3 (Higher scores mean a worse outcome)
Time frame
Day 33
Change in Procalcitonin
Change in serum procalcitonin levels as an inflammatory marker
Time frame
Day 34
Change in IL-6
Change in Interleukin-6 levels (if measured).
Time frame
Day 3Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Pusan National University Yangsan Hospital
Lead sponsor
Vantive Health LLC
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: