Late Evening and Early Morning Protein Supplement to Reduce Readmissions for Hepatic Encephalopathy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ensure Enlive, Standard Of Care.
- Who it may be relevant to
- Registry conditions: Hepatic Encephalopathy. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Dietary supplement Ensure Enlive
The subjects in the intervention group will receive two Ensure Enlive supplements per day for 180 days. - Other Standard Of Care
The subjects in the Standard of care group will continue to receive the standard clinical therapy.
Primary outcome measures
- Determine if decreasing nocturnal fasting by protein supplements will change readmission rates. [Time frame: Day 0 & Day 180]
Eligibility criteria
Inclusion criteria
- > 18 years of age
- cirrhosis diagnosed by clinical history and liver biopsy and/or clinical, biochemical and imaging evidence of cirrhosis
- at least 1 hospitalization for documented HE within the last 12 months.
- abdominal CT scan anytime in the past
Exclusion criteria
- Patients with MELD score > 35
- end stage organ failure (major dysfunction requiring organ support)
- kidney injury defined by a creatinine > 2 mg/dl or rise in creatinine by 0.5 gm/dl from baseline that is unresponsive to withholding diuretics and intravenous albumin administration (1 gm/kg up to 100 gm/day)
- active malignancy
- uncontrolled diabetes mellitus with A1c>9.5 (to avoid altered muscle protein metabolism
- medications (anabolic steroids, corticosteroids) that affect skeletal muscle mass
- recent gastrointestinal surgery within past 12 months
- ongoing infection (positive blood or other body fluid cultures)
- active gastrointestinal bleeding.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Cleveland Clinic Foundation — Cleveland
Identifiers
NCT: NCT04096014 · 18-749