Acute liver failure Acute on chronic liver failure due to hepatitis B Injury, Occupational Diseases, Poisoning
Conditions
Interventions
Upon acquiring the consent form during the subject screening period, the investigator categorizes subjects into groups I, II, III and IV according to the severity grade of hepatic encephalopathy. Half
Sponsors
Gambro Korea Ltd (Korea, South)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Acute liver failure patient in accordance with American Association for the Study of Liver Diseases (AASLD) guideline 2. Age between 20 and 70 3. Patient with a sign of hepatic encephalopathy 4. If a patient is able to make decisions on his/her own, a subject?s own consent and signature is required. However, if a patient is unable to make decisions on his/her own due to hepatic coma, a consent and signature by a legal representative is required. 5. All of the above 6. Or acute-on-chronic liver failure (AoCLF) with hepatitis B including No. 2, 3 and 4 above
Exclusion criteria
Exclusion criteria: 1. Acute liver failure due to acetaminophen 2. Acute hepatitis A 3. Patient with a sign of hepatic encephalopathy due to alcoholic hepatitis 4. Patient with anamnesis of chronic liver disease (except hepatitis B) 5. Among autoimmune disease patients with abrupt recurrence, those who display varix and nodularity on CT or duodenoscopy 6. Patient with anamnesis of hepatocirrhosis (except hepatitis B) 7. Septic shock 8. Patient with irreciprocal multiorgan failure 9. Abrupt bleeding 10. Pregnant or lactating women 11. Patient whose mean arterial pressure (MAP) is below 55 mmHg despite usage of hypertensor 12. Coma of non-hepatic origin 13. Uncontrollable sepsis 14. Extrahepatic cholestasis 15. Extrahepatic neoplasia 16. Patient with irreciprocal brain/organ damage leading to transplantation rejection syndrome 17. HIV hepatitis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6-month survival rate (measured 6 months from the enrolled date of this study) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. In case of no transplantation, one-year survival rate from the date of admittance to the study 2. One-year survival rate post-transplantation 3. Survival period length pre-transplantation 4. An improvement in hepatic encephalopathy (using Glasgow Coma Scale in accordance with Appendix 1); measured every day during hospitalization 5. Bilirubin level improvement after MARS treatment; measured at 1 week, 2 weeks, 3 weeks, 4 weeks, 3 months and 6 months using a biochemical test 6. Laboratory parameter improvement; measured at 1 week, 2 weeks, 3 weeks, 4 weeks, 3 months and 6 months using a biochemical test | — |
Countries
Korea, South
Outcome results
None listed