MedTrace Logo

Human Albumin Infusion in Liver Cirrhosis and Overt Hepatic Encephalopathy (HACHE)

NCT06483737 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 174

Last updated 2025-08-26

No results posted yet for this study

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.

Conditions

  • Overt Hepatic Encephalopathy

Interventions

DRUG

Human albumin infusion at a modified dosage

Participants receive intravenous infusion of human albumin at different dosages according to the serum albumin level.

DRUG

Human albumin infusion at a routine dosage

Participants receive intravenous infusion of human albumin according to the current clinical practice.

DRUG

Lactulose

All participants will receive standard treatment of overt HE according to the current practice guideline.

DRUG

Rifaximin

All participants will receive standard treatment of overt HE according to the current practice guideline.

DRUG

Ornithine Aspartate

All participants will receive standard treatment of overt HE according to the current practice guideline.

DRUG

Branched-Chain Amino Acids

All participants will receive standard treatment of overt HE according to the current practice guideline.

DRUG

Arginine

All participants will receive standard treatment of overt HE according to the current practice guideline.

Sponsors & Collaborators

  • General Hospital of Shenyang Military Region

    lead OTHER

Principal Investigators

  • Xingshun Qi · Department of Gastroenterology, General Hospital of Northern Theater Command

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-24
Primary Completion
2027-06-30
Completion
2027-06-30

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06483737 on ClinicalTrials.gov