RECRUITING

Hepatic Encephalopathy and Albumin Lasting Cognitive Improvement

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Randomized Clinical Trial in Hepatic Encephalopathy to Study Lasting Cognitive Improvement With Intravenous Albumin

Quick Facts

Study Start:2023-11-02
Study Completion:2025-06-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06052176

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age \>18 years
  2. * 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.
  3. * Cognitive impairment defined by MHE on psychometric hepatic encephalopathy score (PHES), critical flicker frequency (CFF), or EncephalApp Stroop
  4. * Prior HE controlled by lactulose or rifaximin for at least one month
  5. * Serum albumin \<4gm/dl
  1. * Unclear diagnosis of cirrhosis
  2. * No prior overt HE
  3. * No cognitive impairment on the tests noted
  4. * Requiring regular albumin infusions within 3 months or anticipated during the study visit
  5. * Infection within a month
  6. * Allergies to albumin
  7. * Unlikely to be adherent to the study
  8. * Unable or unwilling to consent
  9. * West Haven Criteria\>2
  10. * Alcohol abuse within 1 month
  11. * Serum albumin \>4gm/dl
  12. * Congestive heart failure

Contacts and Locations

Study Contact

Jasmohan Bajaj, MD
CONTACT
8046755802
jasmohan.bajaj@vcuhealth.org

Study Locations (Sites)

Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, 23249
United States

Collaborators and Investigators

Sponsor: Hunter Holmes Mcguire Veteran Affairs Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-02
Study Completion Date2025-06-01

Study Record Updates

Study Start Date2023-11-02
Study Completion Date2025-06-01

Terms related to this study

Keywords Provided by Researchers

  • albumin
  • cirrhosis
  • inflammation
  • cognitive performance

Additional Relevant MeSH Terms

  • Cirrhosis
  • Hepatic Encephalopathy