OXiris for Abdominal SEptic Shock (OASES Study)

Официальное название

A Multicenter, Randomized Control Clinical Trial on the Effect of Adsorptive Filter oXiris on Hemodynamics of Abdominal Septic Shock Patients

Обзор

This study innovatively utilizes multi-modal hemodynamic monitoring (Norepinephrine equivalence, NEE+Pulse indicator Continuous Cariac output, PiCCO) to investigate the optimal timing of initiation of oXiris in abdominal infection-associated septic shock patients and to investigate prognosis on sepsis phenotypes undergoing oXiris therapy.

Подробное описание

Sepsis is a life-threatening organ dysfunction syndrome caused by dysregulated host responses to infection, which is one of the leading causes of death for critically ill patients and also a challenge for clinicians.

Abdominal infection is a common cause of septic shock, and is often transferred to intensive care unit (ICU) from emergency surgery, including appendectomy, cholecystectomy, intestinal repair or resection, incision and drainage of abscesses, and local debridement.

The oXiris (Baxter) hemofiltration membrane is the only one on the market with the ability to adsorb both cytokines and endotoxin. This, together with the renal replacement function and its antithrombogenic properties, makes it unique in that it brings together four important functions in a single device. Endotoxin adsorption occurs thanks to a significant number of positively charged free amino groups in Polyethylene imine (PEI), which bind to the negatively charged endotoxin. This capacity is much more important, as oXiris has significantly more PEI compared to previous membranes. Therefore, from the perspective of structural principle, oXiris is currently an ideal adsorptive blood purification filter, which can not only perform conventional renal replacement therapy, but also perform adsorptive therapy to provide extra-renal support for sepsis. Therefore, in terms of the structural properties of the membrane, oXiris is currently an ideal adsorptive blood purification filter for both conventional renal replacement therapy for renal dysfunction treatment and extra-renal support for sepsis with endotoxin adsorption therapy.

The investigaters hypothesis the adsorptive filter oXiris using for continuous renal replacement therapy (CRRT) can improve hemodynamic instability in abdominal septic shock patients, which rely on multimodal hemodynamics monitoring by PiCCO and ultrasound for early goal directed therapy.

Вмешательства

• Устройство CRRT filter
  The subjects will be accepted CRRT using a filter for 72 hours. The subjects will be continued to CRRT or not after 72 hours (the first session of treatment) according to clinical situation by clinician decision. CRRT prescription: 1 Blood purification access: Central vein indwelling double lumen catheter (diameter 11F-13.5F) can be placed in femoral vein, internal jugular vein and subclavian vein; 2.Anti-coagulation prescription: Anticoagulant is used according clinical situation by clinician d

Первичные конечные точки

• The dose of vasopressor agents [Срок оценки: CRRT 0, 6, 12, 24, 48, 72 hours]

Вторичные конечные точки (5)

• The value of PiCCO parameters [Срок оценки: CRRT 0, 6, 12, 24, 36, 48, 72 hours]
• The level of inflammatory markers [Срок оценки: CRRT 0, 12, 24, 48, 72 hours]
• The severity of illness score Severity of illness score [Срок оценки: CRRT 0, 24, 48, 72 hours]
• The time of hospital stay [Срок оценки: From date of randomization until the date of end of followup]
• The number of subjects of survival and kidney recovery [Срок оценки: Day 28, 60, 90]

Критерии участия

Критерии включения

• Age ≥18 years;
• Weight ≥30 kg;
• Intra-abdominal infection (blood or abdominal drainage fluid culture positive for Gram-negative bacteria or suspected to be caused by a Gram-negative agent);
• Diagnostic septic shock (Sepsis 3.0): Sepsis was defined as "life-threatening organ dysfunction caused by a dysregulated host response to infection" with organ dysfunction defined as an increase in qSOFA ⩾2 points. Septic shock was defined as sepsis requiring vasoactive therapy to maintain mean arterial pressure (MAP) ⩾ 65 mmHg and lactate elevation to >2 mmol/L despite adequate volume resuscitation;
• The dose of norepinephrine⩾0.4ug/kg/min;
• PCT⩾50ug/L, and/or IL-6⩾1000pg/ml;
• AKI stage II/III (Kidney Disease Improving Global Outcomes, KDIGO grade);
• Duration of septic shock ≤48 hours.

Критерии исключения

• Patients with highly contagious infectious diseases, such as tuberculosis;
• Pregnant and lying-in woman or lactation period;
• Infection of other sites (no abdominal infection like pneumonia, central nervous system infection and so on);
• CRRT cannot be performed for various reasons;
• Death is expected within 48 hours of admission to the ICU;
• Previous renal replacement therapy;
• Patients that underwent cardio-pulmonary resuscitation (CPR);
• Patients who will not sign the informed consent form.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Renji Hospital, School of Medicine, Shanghai Jiaotong University — Шанхай

Публикации

• Chen J, Zhang Z, Gao J, Liu Y, Zhu B, Gao Y, Zhuang Y, Zhu M. A multicentre, randomised controlled clinical trial evaluating the effect of the adsorptive filter oXiris on haemodynamics in abdominal septic shock patients requiring continuous renal replacement therapy (Oxiris for Abdominal SEptic Shock study). BMJ Open. 2025 Jul 8;15(7):e094792. doi: 10.1136/bmjopen-2024-094792. PMID 40633959

Идентификаторы

NCT: NCT06504316 · LY2024-082-B

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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