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Human Albumin Infusion in Liver Cirrhosis and Overt Hepatic Encephalopathy (HACHE)
Sponsor: General Hospital of Shenyang Military Region
Summary
Hepatic encephalopathy (HE), a severe complication of decompensated cirrhosis, is characterized as neurocognitive dysfunction. Emerging evidence suggests the potential role of human albumin infusion for the treatment of HE, but its optimal dosage remains undefined. Therefore, the investigators planned a randomized controlled trial (RCT) to compare the efficacy of human albumin infusion at different dosages in in patients with liver cirrhosis and overt HE.
Official title: Human Albumin Infusion in Liver Cirrhosis and Overt Hepatic Encephalopathy (HACHE): an Invesitgator-initiated, Open-label, Multicenter, Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
174
Start Date
2025-06-24
Completion Date
2027-06-30
Last Updated
2025-08-26
Healthy Volunteers
No
Conditions
Interventions
Human albumin infusion at a modified dosage
Participants receive intravenous infusion of human albumin at different dosages according to the serum albumin level.
Human albumin infusion at a routine dosage
Participants receive intravenous infusion of human albumin according to the current clinical practice.
Lactulose
All participants will receive standard treatment of overt HE according to the current practice guideline.
Rifaximin
All participants will receive standard treatment of overt HE according to the current practice guideline.
Ornithine Aspartate
All participants will receive standard treatment of overt HE according to the current practice guideline.
Branched-Chain Amino Acids
All participants will receive standard treatment of overt HE according to the current practice guideline.
Arginine
All participants will receive standard treatment of overt HE according to the current practice guideline.
Locations (1)
Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area)
Shenyang, Liaoning, China