Improving cognitive function in cirrhosis patients with albumin treatment
Randomized Clinical Trial in Hepatic Encephalopathy to Study Lasting Cognitive Improvement With Intravenous Albumin
This study is testing if giving albumin through an IV can help improve thinking skills in people with cirrhosis who have had liver-related brain issues.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hunter Holmes Mcguire Veteran Affairs Medical Center Federal |
| Locations | 1 site (Richmond, Virginia) |
| Trial ID | NCT06052176 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of intravenous (IV) 25% albumin on cognitive dysfunction in outpatients with cirrhosis who have experienced hepatic encephalopathy (HE) and minimal hepatic encephalopathy (MHE). The study will assess how long cognitive improvements last after albumin infusion and explore the underlying mechanisms, including changes in inflammatory markers and endothelial function. Participants will receive albumin and saline infusions over eight weeks, with cognitive and health-related quality of life assessments conducted throughout the trial. Each participant will serve as their own control to better evaluate the treatment's efficacy.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with cirrhosis and cognitive impairment due to prior hepatic encephalopathy.
Not a fit: Patients without a clear diagnosis of cirrhosis or those who have not experienced prior overt hepatic encephalopathy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could lead to lasting cognitive improvements for patients suffering from hepatic encephalopathy.
How similar studies have performed: Previous studies have shown promising results with albumin treatment in similar patient populations, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Richmond, Virginia
- Hunter Holmes McGuire VA Medical Center — Richmond, Virginia, United States (Recruiting)
Study contacts
- Study coordinator: Jasmohan Bajaj, MD
- Email: jasmohan.bajaj@vcuhealth.org
- Phone: 8046755802
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.