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
Qualifiers
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
Treatments tested in this trial
- Oxiris Filter (Blood Purification Device)
Treatment groups
62 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Pusan National University Yangsan Hospital
Lead sponsor
Vantive Health LLC
Collaborator
Source ClinicalTrials.gov