Hepatic Encephalopathy and Albumin Lasting Cognitive Improvement

• Status: Recruiting
• Trial end date: 2025-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Hypothesis: Improvement in cognitive dysfunction with IV albumin in patients with cirrhosis with prior HE and MHE lasts for several weeks after albumin infusion has ended, and is due to persistent improvement in inflammatory markers, endothelial dysfunction, albumin function and gut microbial changes.

This will be a single-arm, single-blind sequential trial of IV 25% albumin and IV saline over 8 weeks with biological sampling and cognitive and health related quality of life (HRQOL) testing with each subject acting as their own control.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hunter Holmes Mcguire Veteran Affairs Medical Center
• Collaborator: Grifols Biologicals, LLC

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