Hepatic Encephalopathy and Albumin Lasting Cognitive Improvement
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorHunter Holmes Mcguire Veteran Affairs Medical Center
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Albumin Infusion
Treatment groups
30 Participants
are divided into 2 treatment groupsSponsors and collaborators
Hunter Holmes Mcguire Veteran Affairs Medical Center
Lead sponsor
Grifols Biologicals, LLC
Collaborator
Source ClinicalTrials.gov