Acute liver failure acute-on-chronic liver failure (COSSH-ACLF) caused by HBV
Conditions
Interventions
Control group:Standard treatment for liver failure
Dexamethasone treatment group:Dexamethasone sodium phosphate injection, intravenous push, 10 mg, for 5-7 days (the treatment duration is determined based on the total bilirubin decrease after 5 days o
Sponsors
The First Affiliated Hospital of Army Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-60 years; 2. Liver disease-related symptoms occurred within 3 weeks prior to randomization. 3. Meet the diagnosis of HBV infection with no evidence of decompensation prior to onset (HBsAg positive for >=6 months, or acute HBV infection with positive HBV DNA); 4. Within 3 weeks after onset, diagnosed as acute liver failure (ALF), or pre-acute-on-chronic liver failure (pre-ACLF), or grade 1 (early) acute-on-chronic liver failure (ACLF) according to the Chinese Guidelines for the Diagnosis and Treatment of Liver Failure (2024 Edition) and the COSSH-ACLF criteria by the Chinese Severe Hepatitis B Study Group, meeting any one of the following criteria: (1) Acute liver failure (ALF): Acute onset accompanied by hepatic encephalopathy >= grade II (4-grade classification), and coagulopathy (INR >= 1.5 or PTA 800 U/L; progressive jaundice [5 mg/dL (85.5 µmol/L) = 1 mg/dL (17.1 µmol/L); bleeding tendency; 40% = 12 mg/dL (205.2 µmol/L) combined with: 1.5 <= INR < 2.5, or renal dysfunction (creatinine 1.5-1.9 mg/dL, 132.6-167.96 µmol/L), or hepatic encephalopathy grade I-II.
Exclusion criteria
Exclusion criteria: 1. Liver failure caused by non-HBV factors (e.g., drugs, alcohol, autoimmune liver disease, etc.); 2. Complicated with current infection of hepatotropic viruses such as hepatitis A, C, and E viruses, and non-hepatotropic viruses such as Epstein-Barr virus, cytomegalovirus, and herpes virus; 3. Complicated with intrahepatic or extrahepatic malignant tumors; 4. Malignant jaundice induced by obstructive or hemolytic jaundice, etc.; 5. Liver failure grade II/III (advanced stage) or end-stage liver disease (MELD score > 30); 6. Received immunosuppressive agents or long-acting glucocorticoids for 2 days or more within 4 weeks prior to enrollment; 7. Presence of contraindications to glucocorticoids (e.g., active massive gastrointestinal bleeding, uncontrolled severe infection, diabetic ketoacidosis, history of psychosis, history of dexamethasone allergy, etc.); 8. Female patients who are pregnant or breastfeeding; 9. Predicted to die within 7 days, or willing/plan to receive liver transplantation; 10. Decompensated liver cirrhosis or ascites confirmed by abdominal imaging, or gastrointestinal bleeding or severe esophageal varices revealed by electronic gastroscopy; 11. Severe and poorly controlled diabetes mellitus with HbA1c > 9.0%, frequent hyperglycemic crisis or severe hypoglycemia, or diabetic nephropathy, diabetic retinopathy, diabetic neuropathy; 12. NYHA functional class III-IV cardiac dysfunction, or coronary heart disease with angina pectoris occurring during mild activity or even at rest; 13. Hypertension with persistent blood pressure > 160/100 mmHg, accompanied by left ventricular hypertrophy confirmed by echocardiography or electrocardiography, or elevated serum creatinine with proteinuria; 14. CKD stage 4-5 or glomerular filtration rate < 30 mL/min/1.73 m^2, especially chronic kidney disease with heavy proteinuria or severe complications; 15. Poor compliance; 16. Any other conditions judged by the investigator to be unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 28-day mortality rate for patients without liver transplantation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Decrease in total bilirubin (TBil);3-year HBsAg clearance rate;Number of Serious Adverse Event (SAE) Reports;90-day mortality rate for patients without liver transplantation;Incidence of adverse events within 28 days; | — |
Countries
China
Contacts
Public ContactMao Qing
The First Affiliated Hospital of Army Medical University
Outcome results
None listed