Randomized Clinical Trial to Study Lasting Cognitive Improvement With Intravenous Albumin in Hepatic Encephalopathy

What this Trial Is About

Researchers are studying how intravenous albumin infusions may improve cognitive dysfunction in patients with cirrhosis who have experienced prior hepatic encephalopathy (HE) and currently have minimal hepatic encephalopathy (MHE). The study aims to determine how long these cognitive improvements last after treatment ends and to understand the biological mechanisms involved, such as changes in inflammation, endothelial function, albumin function, and gut microbiota. This is a Phase 2, single-arm, single-blind trial where each participant serves as their own control. Participants will receive intravenous 25% albumin at a dose of 1.5 g/kg ideal body weight and matching volume saline infusions over an 8-week period. The order of albumin and saline infusions is changed during the trial, with both the participants and outcome assessors blinded to the treatment sequence. This design allows comparison of cognitive and biological effects during the albumin and saline phases. Throughout the study, participants will undergo biological sampling and repeated assessments of cognitive function and health-related quality of life. Measures include the Psychometric Hepatic Encephalopathy Score (PHES), EncephalApp Stroop, Critical Flicker Frequency, and various blood and stool markers related to inflammation and albumin function. The primary outcome is the change in PHES score between the saline and albumin phases over 4 weeks each. The total trial duration includes these treatment periods with monitoring of cognitive and biological changes.

Hepatic Encephalopathy and Albumin Lasting Cognitive Improvement