Acute-on-Chronic Liver Failure (ACLF)
Conditions
Interventions
Intervention group:Receiving a late evening snack (LES) with a liver disease–specific BCAA-enriched formula
Control group:Receiving a late evening snack (LES) consisting of an isocaloric, nitrogen-free pure carbohydrate formula
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Voluntary participation in the study, with the ability to understand the study objectives, procedures, and potential risks, and provision of written informed consent. 2. Aged 18–70 years (inclusive), regardless of sex; 3. Progressive worsening of jaundice in the short term, defined as serum total bilirubin >12× the upper limit of normal or a daily increase >=17.1 µmol/L; 4. International normalized ratio (INR) =1.5, with other causes excluded; 5. Presence of chronic liver disease, defined as a history of =6 months, or evidence from liver fibrosis markers, or imaging findings suggestive of chronic liver disease; 6. At enrollment, participants are able to tolerate oral intake and comply with the late evening snack (LES) intervention as per protocol; 7. At enrollment, relatively stable vital signs, without the need for high-dose vasopressors or mechanical ventilation due to severe respiratory failure.
Exclusion criteria
Exclusion criteria: 1. Refusal or inability to provide written informed consent; 2. Prior liver transplantation, or listed for urgent liver transplantation with an expected transplant within 72 hours; 3. Presence of advanced malignancy or other severe systemic diseases with an expected survival of <3 months; 4. Severe renal dysfunction (e.g., eGFR <30 mL/min/1.73 m² or receiving long-term dialysis), where high-protein or high-BCAA intervention is considered inappropriate by the investigator; 5. Severe hepatic encephalopathy (West Haven grade III–IV), requiring airway protection or deep sedation, with inability to resume oral intake in the short term; 6. Presence of acute severe complications at enrollment requiring fasting and urgent management, such as active massive gastrointestinal bleeding, severe acute pancreatitis, or intestinal obstruction; 7. Known severe allergy or intolerance to components of the study nutritional supplements (e.g., dairy protein, excipients in BCAA formulations); 8. Pregnant or breastfeeding women; 9. Participation in other interventional clinical trials within the past 3 months that may interfere with the results of this study; 10. Any condition that, in the investigator’s judgment, makes the participant unsuitable for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relative change in L3 skeletal muscle index (L3-SMI) at Day 28; | — |
Secondary
| Measure | Time frame |
|---|---|
| 28-day transplant-free survival (TFS);90-day transplant-free survival (TFS);Changes in disease severity scores (MELD, MELD-Na, and COSSH-ACLF-related scores);Serum albumin;Incidence and grade of hepatic encephalopathy (HE);Incidence of other liver-related complications;Changes in handgrip strength (HGS);Changes in Liver Frailty Index (LFI);Changes in Chronic Liver Disease Questionnaire (CLDQ) scores;Late-evening snack (LES) adherence;Incidence of adverse events (AE) and serious adverse events (SAE);Gut microbiota structural characteristics by 16S rRNA sequencing;Total bilirubin;International normalized ratio (INR);Serum creatinine;Blood ammonia;C-reactive protein (CRP); | — |
Countries
China
Contacts
Public ContactChunhai Shao
Huashan Hospital, Fudan University
Outcome results
None listed