Human Albumin Infusion in Liver Cirrhosis and Overt Hepatic Encephalopathy (HACHE): an Invesitgator-initiated, Open-label, Multicenter, Randomized Controlled Trial
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
China
Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area)
RECRUITING
Shenyang
Contact Information
Primary
Xingshun Qi
xingshunqi@126.com
18909881019
Backup
Qianqian Li
1208594776@qq.com
13940307473
Time Frame
Start Date: 2025-06-24
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 174
Treatments
Experimental: Modified dosage group
Intravenous infusion of human albumin 30-60g.
Active_comparator: Routine dosage group
Intravenous infusion of human albumin 10-20g.
Related Therapeutic Areas
Sponsors
Leads: General Hospital of Shenyang Military Region