Status:
RECRUITING
Hepatic Encephalopathy and Albumin Lasting Cognitive Improvement
Lead Sponsor:
Hunter Holmes Mcguire Veteran Affairs Medical Center
Collaborating Sponsors:
Grifols Biologicals, LLC
Conditions:
Cirrhosis
Hepatic Encephalopathy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 imp...
Detailed Description
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...
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
Key Trial Info
Start Date :
November 2 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06052176
Start Date
November 2 2023
End Date
October 1 2026
Last Update
February 11 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, United States, 23249