Hepatic Encephalopathy and Albumin Lasting Cognitive Improvement

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-02

Study Completion Date

2026-10-01

Brief Summary

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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.

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Detailed Description

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In outpatients with cirrhosis with prior HE who have cognitive impairment despite adequate therapy, how long the impact of albumin lasts and through which potential mechanism(s) needs to be determined.

A prior recent HEAL trial showed that patients with prior HE and current minimal hepatic encephalopathy (MHE) randomized to albumin experienced significant improvement in cognitive dysfunction and psychosocial quality of life. Moreover, these improvements persisted a week after the last albumin infusion, which was not seen in the placebo group. This was accompanied by an improvement in endothelial dysfunction, ischemia-modified albumin levels and inflammatory markers that persisted one week even after albumin discontinuation. The reported half-life of IV albumin is 2 weeks, but the function and the length of time of albumin's action in decompensated cirrhosis is lower, and further details surrounding albumin pharmacokinetics in this population remain unelucidated. The mechanisms and length of time albumin's potential improvement for patients with MHE after treatment discontinuation also require continued study.

Study design:

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.

Th order of the albumin and placebo infusion and blind the infusions from the subjects and the assessors of the outcomes will be changed.

Conditions

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Cirrhosis Hepatic Encephalopathy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Subjects will be blinded to which infusions are albumin versus placebo. All infusion tubing and bag will be covered in foil and the subjects will not be aware of the timing of the saline vs albumin infusion to maintain blinding for the patient.

Study Groups

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Placebo

Saline given at the same volume as the albumin on visits the patients are assigned to it

Group Type PLACEBO_COMPARATOR

Albumin Infusion

Intervention Type DRUG

Intravenous human serum albumin to be given at 1.5g/kg ideal body weight

Albumin

IV Albumin at 1.5g/kg ideal body weight

Group Type ACTIVE_COMPARATOR

Albumin Infusion

Intervention Type DRUG

Intravenous human serum albumin to be given at 1.5g/kg ideal body weight

Interventions

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Albumin Infusion

Intravenous human serum albumin to be given at 1.5g/kg ideal body weight

Intervention Type DRUG

Other Intervention Names

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Albutein

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No