Decompensated cirrhosis is associated with poor outcomes, especially when combined with sarcopenia. Cirrhosis, Sarcopenia, Beta-hydroxy beta-methylbutyrate
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged more than 18-years-old 2. Decompensated cirrhosis cirrhosis includes either of the following criteria - liver biopsy or - history of complications related to cirrhosis, such as ascites, variceal bleeding, hepatic encephalopathy or - meeting 2 out of 4 criteria of transient elastography > 13 kPa, radiological assessments showing features consistent with cirrhosis (enlarged liver, dilated portal veins, or the presence of ascites), APRI greater than 2.0, and EGD revealing signs of varices. - Decompensated cirrhosis is defined by the presence or history of overt PHT-related bleeding, ascites of at least grade 2, overt hepatic encephalopathy, or a Child-Pugh score of B or C. 3. Sarcopenia criteria by the Asian Working Group for Sarcopenia and the extended criteria of reduced muscle mass use a threshold in international criteria
Exclusion criteria
Exclusion criteria: 1. active cancer 2. untreated chronic hepatitis B or C 3. alcohol consumption within the past 6 months 4. severe active infections 5. chronic kidney disease (CKD) stage 4 or 5 6. uncontrolled diabetes defined by HbA1C > 9% 7. active heart failure defined by New York Heart Association (NYHA) class III or IV 8. chronic obstructive pulmonary disease GOLD C or D 9. limitations for conducting bioelectrical impedance analysis (BIA) measurements presence of metal implants in the body, limb disability or amputation, pregnancy, use of a cardiac pacemaker or implantable cardiac resynchronization therapy 10. post-liver transplantation (LT) or LT waiting list 11. Eastern Cooperative Oncology Group (ECOG) performance status 3 or 4 12. ascites grade 3 or refractory ascites 13. recent spontaneous bacterial peritonitis or gastrointestinal bleeding, or hepatic encephalopathy within the last 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Muscle mass 12 week, 24 week bioelectrical impedance analysis (BIA) | — |
Secondary
| Measure | Time frame |
|---|---|
| muscle performance ,muscle strength, body composition 12 week, 24 week bioelectrical impedance analysis (BIA),the rate of hospitalization, decompensated events, and mortality 12 week, 24 week questionnaire interview | — |
Countries
Thailand
Contacts
Faculty of Medicine, Khon Kaen University