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Late Evening and Early Morning Protein Supplement to Reduce Readmissions for Hepatic Encephalopathy
Sponsor: The Cleveland Clinic
Summary
Readmission rates for patients with hepatic encephalopathy due to end stage liver disease are high. Hyperammonemia contributes significantly to encephalopathy and occurs because of impaired hepatic ureagenesis and increased skeletal muscle proteolysis. We propose a randomized, 6-month nutritional intervention in cirrhotic patients who have had at least 1 admission for hepatic encephalopathy within the last 6 months. We hypothesize that a combination of late evening and early morning protein supplement (Ensure Enlive) will decrease recurrent hepatic encephalopathy and consequent readmission rates by lowering skeletal muscle proteolysis and improved lean body mass.
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2019-09-16
Completion Date
2026-10-30
Last Updated
2025-11-25
Healthy Volunteers
No
Conditions
Interventions
Ensure Enlive
The subjects in the intervention group will receive two Ensure Enlive supplements per day for 180 days.
Standard Of Care
The subjects in the Standard of care group will continue to receive the standard clinical therapy.
Locations (1)
Cleveland Clinic Foundation
Cleveland, Ohio, United States