HBV Clinical Trial
Official title:
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
The AARC China Study is to establish a widely recognized and harmonized standard of patients with HBV-ACLF in the Asia Pacific region.
Status | Recruiting |
Enrollment | 3000 |
Est. completion date | April 1, 2023 |
Est. primary completion date | April 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Chronic liver disease: Chronic hepatitis B - Acute deterioration of liver function: more than one of the below criteria 1. 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) 2. development of hepatic encephalopathy 3. development of gastrointestinal hemorrhage 4. development of jaundice (serum bilirubin greater than or equal to 3mg/dl) 5. 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. Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
China | Department of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei |
Lead Sponsor | Collaborator |
---|---|
Qin Ning |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Non-liver transplant mortality | Non-liver transplant mortality rate at 30 days, 90 days | 30 days, 90 days | |
Secondary | progression of Chronic liver disease | Incidence of liver disease progression (such as cirrhosis, decompensation of liver function, liver cancer, liver transplantation, or liver related death) | 3 years |
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