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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

Eligibility

Primary outcome measure(s)

• Change of overt HE. — 3-5 days
  The change of HE is defined as a decrease or an increase of at least one grade of the West Haven criteria after treatment.

Trial sites (1)

More General Hospital of Shenyang Military Region trials in China