Albumin for Cognitive Improvement in Cirrhosis and Hepatic Encephalopathy

This study is looking into whether intravenous (IV) albumin (a protein found in blood) can improve thinking and memory problems in people with cirrhosis (scarring of the liver) and hepatic encephalopathy (HE, a brain disorder caused by liver disease). Researchers want to see if these improvements last for several weeks after albumin infusions stop. You might be able to join if you are over 18, have cirrhosis, and have experienced HE. The study will measure changes in your cognitive function using a test called the Psychometric Hepatic Encephalopathy Score (PHES) to see if albumin is effective. The study status is currently unclear.

Study design
This is a single-arm, single-blind study, meaning all 30 participants will receive both albumin and saline, and you won't know which you're getting at a given time. You will act as your own control, comparing your results during the albumin phase to the saline phase.
What's involved
You will receive IV 25% albumin and IV saline over an 8-week period. This will involve biological sampling and cognitive and health-related quality of life testing.
Compensation
Not stated in the trial record.
Follow-up
Your cognitive function will be measured at 4 weeks after both the placebo and albumin phases.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06052176

Hepatic Encephalopathy and Albumin Lasting Cognitive Improvement

Active, Not Recruiting
PHASE2Ages 18+InterventionalPrevention
Hunter Holmes Mcguire Veteran Affairs Medical Center
~25 participants
Updated 2026-08-25 on ClinicalTrials.gov
What's tested:Albumin Infusion

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Delta change in Psychometric Hepatic Encephalopathy Score (PHES) in Placebo phase vs Albumin phase
Measured over 4 weeks each
Cirrhosis
Hepatic Encephalopathy
1 sites across 1 states
Virginia1

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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
  • Delta change in Psychometric Hepatic Encephalopathy Score (PHES) in Placebo phase vs Albumin phase4 weeks each

    cognitive improvement (PHES score ranges from -15 to 5), higher is good