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

N/ANot Yet RecruitingNCT07334327

Pusan National University Yangsan Hospital62 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Septic Shock Multi Organ Failure

Interventions

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.

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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 initiation

Secondary Outcomes

All-cause mortality

Percentage of participants who died from any cause

Time frame: Day 28

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 3

Change in Procalcitonin

Change in serum procalcitonin levels as an inflammatory marker

Time frame: Day 3

Change in IL-6

Change in Interleukin-6 levels (if measured).

Time frame: Day 3

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

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts