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

Официальное название

Efficacy of eXtracorPoreal bLOod puRification Using oXiris in Patients With SEptic Shock: A Multicenter Propensity-matched Cohort Study (EXPOLRE Study)

Обзор

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.

Вмешательства

• Устройство 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

Первичные конечные точки

• Composite of early organ dysfunction and mortality at Day 7 [Срок оценки: 7 days after treatment initiation]

Вторичные конечные точки (4)

• All-cause mortality [Срок оценки: Day 28]
• Change in Sequential Organ Failure Assessment(SOFA) score [Срок оценки: Day 3]
• Change in Procalcitonin [Срок оценки: Day 3]
• Change in IL-6 [Срок оценки: Day 3]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07334327 · 23-2025-005

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗