What this study is
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.
What's being tested
- Ensure Enlive
Intervention · DIETARY SUPPLEMENT
The subjects in the intervention group will receive two Ensure Enlive supplements per day for 180 days.
- Standard Of Care
Intervention · OTHER
The subjects in the Standard of care group will continue to receive the standard clinical therapy.
Study details
- Sponsor
- The Cleveland Clinic
- Conditions
- Hepatic Encephalopathy
- Enrolling
- 40 people
- Starts
- 2019-09-16
- Est. completion
- 2028-10-30
- Design
- Single-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 75 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- > 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
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openCleveland Clinic Foundation
Cleveland, Ohio, United States
- Annette Bellar, BS · Contact216-445-6268bellara@ccf.org
- Revathi Penumatsa · Contactpenumar@ccf.org
- Srinivasan Dasarathy, MD · Principal investigator
Recruiting
Study team
Sponsor
The Cleveland Clinic
Study ID 18-749
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.