Late Evening and Early Morning Protein Supplement to Reduce Readmissions for Hepatic Encephalopathy

Study Overview
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Brief Summary
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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.

Official Title
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Late Evening and Early Morning Protein Supplement to Reduce Readmissions for Hepatic Encephalopathy

Conditions
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Hepatic Encephalopathy

Intervention / Treatment
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* Dietary Supplement: Ensure Enlive
* Other: Standard Of Care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ensure Enlive<br> | Dietary Supplement: Ensure Enlive<br>* The subjects in the intervention group will receive two Ensure Enlive supplements per day for 180 days.<br>Other: Standard Of Care<br>* The subjects in the Standard of care group will continue to receive the standard clinical therapy.<br>|
| Placebo Comparator: Standard of Care<br> | Other: Standard Of Care<br>* The subjects in the Standard of care group will continue to receive the standard clinical therapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine if decreasing nocturnal fasting by protein supplements will change readmission rates. | Change in number of readmissions | Day 0 & Day 180 |