Actively Recruiting
Late Evening and Early Morning Protein Supplement to Reduce Readmissions for Hepatic Encephalopathy
Led by The Cleveland Clinic · Updated on 2025-11-25
40
Participants Needed
1
Research Sites
371 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Late Evening and Early Morning Protein Supplement to Reduce Readmissions for Hepatic Encephalopathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Over 18 years of age
- Diagnosed with cirrhosis by clinical history and liver biopsy and/or clinical, biochemical and imaging evidence
- At least one hospitalization for documented hepatic encephalopathy within the last 12 months
- Have had an abdominal CT scan at any time in the past
You will not qualify if you...
- MELD score greater than 35
- End stage organ failure requiring organ support
- Kidney injury with creatinine over 2 mg/dl or unresponsive to treatment
- Active malignancy
- Uncontrolled diabetes with A1c over 9.5
- Use of anabolic steroids or corticosteroids affecting muscle mass
- Recent gastrointestinal surgery within the past 12 months
- Ongoing infection with positive cultures
- Active gastrointestinal bleeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Actively Recruiting
Research Team
A
Annette C Bellar
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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