Hepatic Encephalopathy and Albumin Lasting Cognitive Improvement

Launched by HUNTER HOLMES MCGUIRE VETERAN AFFAIRS MEDICAL CENTER · Sep 18, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at whether a treatment called intravenous (IV) albumin can help improve thinking and memory problems in people with cirrhosis who have experienced hepatic encephalopathy (HE), a condition that affects brain function. Researchers believe that the benefits of albumin may last for several weeks even after the treatment has stopped, and they will measure changes in inflammation, blood vessel function, and gut bacteria to understand why this happens. The study will involve giving participants either IV albumin or a saline solution over eight weeks, while also assessing their cognitive abilities and quality of life.

To participate in this trial, individuals must be over 18 years old and have a confirmed diagnosis of cirrhosis, along with some cognitive impairment. They should have experienced symptoms of HE in the past but have been stable for at least a month. Participants will not be able to join if they have certain health issues, like active infections or heart failure, or if they have had recent alcohol abuse. Throughout the study, participants can expect regular evaluations of their health and cognitive function to see how the treatment affects them. This trial is currently recruiting, and all genders are welcome to apply.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age \>18 years
• • Cirrhosis diagnosed using either (a) liver biopsy, (b) transient wave elastography (\>20 KPa) (c) radiological evidence consistent with cirrhosis, (d) in a patient with chronic liver disease endoscopic or radiological evidence of varices (e), in a patient with chronic liver disease, platelet count \<150,000/mm3 and AST/ALT ratio \>1.
• • Cognitive impairment defined by MHE on psychometric hepatic encephalopathy score (PHES), critical flicker frequency (CFF), or EncephalApp Stroop
• • Prior HE controlled by lactulose or rifaximin for at least one month
• • Serum albumin \<4gm/dl
• Exclusion Criteria:
• • Unclear diagnosis of cirrhosis
• • No prior overt HE
• • No cognitive impairment on the tests noted
• • Requiring regular albumin infusions within 3 months or anticipated during the study visit
• • Infection within a month
• • Allergies to albumin
• • Unlikely to be adherent to the study
• • Unable or unwilling to consent
• • West Haven Criteria\>2
• • Alcohol abuse within 1 month
• • Serum albumin \>4gm/dl
• • Congestive heart failure