Registry Study for Optimal Management of Liver Failure in the Chinese Population

Официальное название

Registry Study for Optimal Management of Liver Failure in the Chinese Population (RESOLVE-C)

Обзор

Liver failure is the most severe form of liver damage caused by viral, alcoholic, drug-related and ischemia-reperfusion factors, often combined with extrahepatic organ damage, resulting in a high mortality rate. This study intends to construct a real-world case registry database of inpatients with liver failure based on an electronic clinical data collection system through a multicenter collaborative network to study the clinical characteristics, epidemiology of bacterial and fungal infections, the impact of sarcopenia on clinical prognosis, and optimization of treatment strategies such as antiviral and artificial liver in Chinese inpatients with liver failure. The cohort and experience generated from this study will be used as a support for a series of future studies to focus on clinical issues such as infection, end-stage liver disease combined with organ failure, and early warning of critically ill patients.

Вмешательства

• Процедура ALF
  Acute onset, no history of underlying liver disease, liver failure characterized by degree Ⅱ or above hepatic encephalopathy developed within 2 weeks
• Процедура SALF
  The onset was acute, with no history of underlying liver disease, and clinical manifestations of liver failure appeared between 2 and 26 weeks
• Процедура ACLF
  On the basis of chronic liver disease, the clinical manifestations of acute liver decompensation and liver failure appear in a short period

Первичные конечные точки

• Overall survival [Срок оценки: 28-day]
• Overall survival [Срок оценки: 90-day]

Вторичные конечные точки (1)

• Disease progression [Срок оценки: 48 weeks after discharge]

Критерии участия

Критерии включения

Patients with a diagnosis consistent with liver failure and pre-liver failure:

• Extreme weakness with significant gastrointestinal symptoms such as anorexia, vomiting and abdominal distention;
• Elevated alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) with progressive jaundice (TBil≥85.5 μmol/L);
• Bleeding tendency with PTA ≤ 60% or INR ≥ 1.5.

Критерии исключения

• An event or complication that, in the judgment of the investigator, significantly affects the assessment of clinical status.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 14 центров

• First Affiliated Hospital of Xi'an Jiaotong University — Сиань
• Ankang Central Hospital — Ankang
• Xiangya Hospital of Central South University — Чанша
• Hanzhong 3201 Hospital — Hanzhong
• Qilu Hospital of Shandong University — Цзинань
• First Hospital of Lanzhou University — Lanzhou
• Weinan Central Hospital — Weinan
• Air Force Medical University Tangdu Hospital — Сиань
• … и ещё 6 центров

Публикации

• Liu Y, Zhang Q, Li J, Wu X, Zang Q, Wang Q, Huang P, Wang Y, Zhang S, Liu S, Zhu C, Zhao Y, Yan T, He Y. mNGS improves the efficiency of infection diagnosis and treatment in acute-on-chronic liver failure. BMC Gastroenterol. 2026 Jan 20;26(1):129. doi: 10.1186/s12876-025-04601-8. PMID 41559596

Идентификаторы

NCT: NCT05740696 · XJTU1AF2023LSK-019

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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