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

General Hospital of Northern Theater Command of Chinese People's Liberation Army

Status: Enrolling

Conditions: Overt Hepatic Encephalopathy

Treatments: Drug: Lactulose; Drug: Human albumin infusion at a modified dosage; Drug: Branched-Chain Amino Acids; Drug: Human albumin infusion at a routine dosage; Drug: Arginine; Drug: Rifaximin; Drug: Ornithine Aspartate

Study type: Interventional

Funder types: Other

Identifiers

NCT06483737

XHNKKY-OHE-RCT

Details and patient eligibility

About

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.

Full description

Overall, 174 patients with a diagnosis of liver cirrhosis, overt HE, and a serum albumin level of 23-30g/L will be enrolled. They will be stratified according to the severity of overt HE and randomly assigned at a ratio of 1:1 into the groups of human albumin infusion at a modified dosage and a routine dosage. The primary endpoint is the improvement of overt HE within 3-5 days after treatment. The secondary endpoints include recurrence of overt HE, survival, and adverse events.

Enrollment: 174 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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174 participants in 2 patient groups

Modified dosage group

Experimental group

Description:

Intravenous infusion of human albumin 30-60g.

Treatment:

Drug: Ornithine Aspartate

Drug: Rifaximin

Drug: Arginine

Drug: Branched-Chain Amino Acids

Drug: Human albumin infusion at a modified dosage

Drug: Lactulose

Routine dosage group

Active Comparator group

Description:

Intravenous infusion of human albumin 10-20g.

Treatment:

Drug: Ornithine Aspartate

Drug: Rifaximin

Drug: Arginine

Drug: Branched-Chain Amino Acids

Drug: Human albumin infusion at a routine dosage

Drug: Lactulose