Efficacy of eXtracorPoreal bLOod puRification Using oXiris in Patients With SEptic Shock: A Multicenter Propensity-matched Cohort Study (EXPOLRE Study)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 62
- 主要终点
- Composite of early organ dysfunction and mortality at Day 7
研究概览
简要总结
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:
- Receive blood purification therapy using the Oxiris filter for up to 3 days while in the intensive care unit (ICU).
- Have their blood tested at the start of the study and 3 days later to check for inflammation and organ function.
- Be followed by the research team for about 30 days to check on their health and recovery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Composite of early organ dysfunction and mortality at Day 7
时间窗: 7 days after treatment initiation
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.
次要结局
- All-cause mortality(Day 28)
- Change in Procalcitonin(Day 3)
- Change in IL-6(Day 3)
- Change in Sequential Organ Failure Assessment(SOFA) score(Day 3)
研究者
Woo Hyun Cho
Professor
Pusan National University Yangsan Hospital