A Study of APASL ACLF Research Consortium (AARC) Standards on Diagnosis and Treatment of Patients With Hepatic B Virus Related Acute on Chronic Liver Failure (HBV-ACLF) in China (AARC China Study)： a Multicentre Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Non-liver transplant mortality
研究概览
简要总结
The AARC China Study is to establish a widely recognized and harmonized standard of patients with HBV-ACLF in the Asia Pacific region.
详细描述
Acute on chronic liver failure (ACLF) is a clinically critical illness and has been extensively researched around the world. However, there is a potential "communication barrier" in the ACLF study; that is, different countries and regions, or different research collaboration groups, follow different ACLF definitions and related standards, making researchers in this field confuse in understanding the research value of relevant research and interpreting the research results. Important differences exist in the Asia-Pacific region and North America and Europe, such as the etiology, the clinical characteristics of the patient group, the requirements for cirrhosis, and the predisposing factors of the disease, making it necessary for China or the Asia-Pacific region to develop appropriate ACLF diagnosis standards and prognosis. In recent years, Chinese experts have also focused on the research progress of APASL ACLF Research Consortium (AARC) in the Asia-Pacific region. It is found that the AARC standards are more suitable for the diagnosis and treatment of patients with ACLF in China than the Western standards. The ACLF prediction model (TPPM model) established by Professor Qin.N's team predicts that the prognostic efficacy of patients with HBV-ACLF is significantly better than that of Western prognosis. The AARC China Study is to establish a widely recognized and harmonized standard of patients with HBV-ACLF in the Asia Pacific region.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic liver disease: Chronic hepatitis B
- •Acute deterioration of liver function: more than one of the below criteria
- •development of new ascites within 4 weeks or re-emergence of ascites who have previous well controlled ascites (greater than or equal to grade 2 or 3; International ascites club criteria)
- •development of hepatic encephalopathy
- •development of gastrointestinal hemorrhage
- •development of jaundice (serum bilirubin greater than or equal to 3mg/dl)
- •development of bacterial infection
- •spontaneous bacteremia: positive blood cultures without a source of infection
- •spontaneous bacterial peritonitis: ascitic fluid polymorphonuclear cells >250/µL
- •lower respiratory tract infections: new pulmonary infiltrate in the presence of: i) at least one respiratory symptom (cough, sputum production, dyspnea, pleuritic pain) with ii) at least one finding on auscultation (rales or crepitation) or one sign of infection (core body temperature >38_C or less than 36_C, shivering, or leukocyte count >10,000/mm3 or <4,000/mm3) in the absence of antibiotics
- •Clostridium difficile Infection: diarrhea with a positive C. difficile assay
- •bacterial entero-colitis: diarrhea or dysentery with a positive stool culture for Salmonella, Shigella, Yersinia, Campylobacter, or pathogenic E. coli;
- •soft-tissue/skin Infection: fever with cellulitis
- •urinary tract infection (UTI): urine white blood cell >15/high-power field with either positive urine gram stain or culture;
- •intra-abdominal infections: diverticulitis, appendicitis, cholangitis, etc.
- •other infections not covered above;
- •fungal infections as a separate category.
排除标准
- •Patients who do not have chronic liver disease
- •Patients who have hepatocellular carcinoma
- •Patients who admitted for extrahepatic manifestations
- •Patients who have HIV infection
- •Patients who admitted for symptomatic control of chronic liver disease, other than acute deterioration of liver function
结局指标
主要结局
Non-liver transplant mortality
时间窗: 30 days, 90 days
Non-liver transplant mortality rate at 30 days, 90 days
次要结局
- progression of Chronic liver disease(3 years)
研究者
Qin Ning
Director and Chair of Department of Infectious Diseases
Tongji Hospital