Идёт набор NCT05030571

The Effects of Double Plasma Molecular Adsorption System in Acute on Chronic Liver Failure Patients

Без фазы С лечением Acute-On-Chronic Liver Failure Acute on Chronic Hepatic Failure

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: DPMAS, standard treatment.
Кому может быть актуально: Состояния в реестре: Acute-On-Chronic Liver Failure, Acute on Chronic Hepatic Failure. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Таиланд
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

Acute liver failure patients posed high mortality rate despite receiving standard therapy. The severity and mortality even higher in patients with underlying liver disease. Acute liver failure cause hyperinflammatory response in early stage and immunoparalysis in later stage. The surge of proinflammatory cytokines leads to multiorgan failure and more liver injury. Subsequent immunoparalysis may lead to lethal secondary infections. Liver support system had been used in acute and acute ontop chronic liver disease for last several decades. Double plasma molecular adsorption system (DPMAS) is one of the promising non-biological liver support system that have been extensively investigated in acute ontop chronic liver failure from hepatits B viral. DPMAS circuit consist of BS330 (bilirubin adsorber) and HA330 (Cytokines adsorber). Thus, DPMAS can also remove various cytokines. The effect of DPMAS on immune function in these patients has not been explored. Recent randomized controlled trial by Srisawat et al. demonstrated improvement of mHLA-DR in septic shock patients who received polymyxin B extracorporeal therapy compare to control arm. Since liver failure show change of immunological profile resemble to sepsis. Investigators proposed that removal of toxic liver toxins and lethal cytokines by DPMAS will improve immunological profiles in acute ontop chronic liver failure patients. Investigators plan to conduct a randomized controlled trial in acute ontop chronic liver failure patients who admitted to intensive care unit. Investigators plan to compare the immunomodulatory effects of DPMAS with standard treatments.

Вмешательства

Устройство DPMAS
DPMAS circuit consist of Plasmaflo OP cartridge (Asahi Medical, Tokyo, Japan), Ion exchange resin hemoperfusion cartridge (BS330; Jafron, Zhuhai City, China), and Neutral adsorption resin hemoperfusion cartridge (HA330-II; Jafron, Zhuhai City, China)
Другое standard treatment
standard treatment according to EASL Clinical Practical Guidelines on the management of acute (fulminant) liver failure 2017.

Первичные конечные точки

mHLA-DR expression [Срок оценки: 7 days]

Вторичные конечные точки (5)

survival rate [Срок оценки: 28 days]
Reduction of total bilirubin [Срок оценки: 7 days]
hepatic encephalopathy grading [Срок оценки: 28 days]
subsequent bacterial infection [Срок оценки: 28 days]
CD11b expression [Срок оценки: 7 days]

Критерии участия

Критерии включения

Age 18 or more
Diagnosis of Acute ontop chronic liver failure by Asian Pacific association for the study of the liver (APASL) criteria
Admitted to intensive care unit