RecruitingPhase 2NCT06052176

Hepatic Encephalopathy and Albumin Lasting Cognitive Improvement

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

Sponsor

Hunter Holmes Mcguire Veteran Affairs Medical Center

Enrollment

30 participants

Start Date

Nov 2, 2023

Study Type

INTERVENTIONAL

Conditions

Cirrhosis Hepatic Encephalopathy

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria5

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 Criteria12

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