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

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

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Albumin Infusion for people with cirrhosis and hepatic encephalopathy. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAlbumin Infusion

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


Locations(1)

Hunter Holmes McGuire VA Medical Center

Richmond, Virginia, United States

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NCT06052176


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