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

NeuroTherapia, Inc.

Status: Enrolling

Conditions: Hepatic Encephalopathy

Treatments: Dietary Supplement: Ensure Enlive; Other: Standard Of Care

Study type: Interventional

Funder types: Other

Identifiers

NCT04096014

18-749

Details and patient eligibility

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups, including a placebo group

Ensure Enlive

Active Comparator group

Treatment:

Other: Standard Of Care

Dietary Supplement: Ensure Enlive

Standard of Care

Placebo Comparator group

Treatment:

Other: Standard Of Care