Hepatic Encephalopathy and Albumin Lasting Cognitive Improvement

Description

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.

Conditions

Cirrhosis, Hepatic Encephalopathy

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Study Overview

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Study Details

Study overview

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.

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

Hepatic Encephalopathy and Albumin Lasting Cognitive Improvement

Condition
Cirrhosis
Intervention / Treatment

-

Contacts and Locations

Richmond

Hunter Holmes McGuire VA Medical Center, Richmond, Virginia, United States, 23249

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Hunter Holmes Mcguire Veteran Affairs Medical Center,

Study Record Dates

2025-06-01