Human Albumin Infusion in Liver Cirrhosis and Overt Hepatic Encephalopathy (HACHE)
Human Albumin Infusion in Liver Cirrhosis and Overt Hepatic Encephalopathy (HACHE): an Invesitgator-initiated, Open-label, Multicenter, Randomized Controlled Trial
General Hospital of Shenyang Military Region
174 participants
Jun 24, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- A definite diagnosis of liver cirrhosis and overt HE
- A serum albumin level of 23-30g/L
- Age ≥18 years old
- Sign the informed consent
Exclusion Criteria6
- Contraindications to human albumin infusion
- A history of transjugular intrahepatic portosystemic shunt
- A diagnosis of acute liver failure
- Severe heart and/or lung diseases
- Psychiatric or nervous diseases
- Pregnant or lactating
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Interventions
Participants receive intravenous infusion of human albumin at different dosages according to the serum albumin level.
Participants receive intravenous infusion of human albumin according to the current clinical practice.
All participants will receive standard treatment of overt HE according to the current practice guideline.
All participants will receive standard treatment of overt HE according to the current practice guideline.
All participants will receive standard treatment of overt HE according to the current practice guideline.
All participants will receive standard treatment of overt HE according to the current practice guideline.
All participants will receive standard treatment of overt HE according to the current practice guideline.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06483737