The Effects of beta-hydroxy-beta-methylbutyrate supplementation in decompensated cirrhosis patients with sarcopenia: Randomize controlled trial, Preliminary Study

Khon Kaen University0 个研究点目标入组 23 人开始时间: 2024年4月22日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•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

•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.

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