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

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.

Study Overview

• Status: Recruiting
• Conditions: Hepatic Encephalopathy
• Intervention / Treatment: Dietary supplement: Ensure Enlive; Other: Standard Of Care

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Annette C Bellar; Phone Number: 2166365247 2166365247; Email: bellara@ccf.org

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Cleveland Clinic Foundation
      • Contact: Revathi Penumatsa; Email: penumar@ccf.org
      • Contact: Annette Bellar, BS; Phone Number: 216-445-6268; Email: bellara@ccf.org
      • Principal Investigator: Srinivasan Dasarathy, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Standard of Care	Other: Standard Of Care; The subjects in the Standard of care group will continue to receive the standard clinical therapy.
Active Comparator: Ensure Enlive	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2019
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): October 30, 2024

Study Registration Dates

• First Submitted: September 11, 2019
• First Submitted That Met QC Criteria: September 17, 2019
• First Posted (Actual): September 19, 2019

Study Record Updates

• Last Update Posted (Actual): June 27, 2023
• Last Update Submitted That Met QC Criteria: June 26, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Failure; Hepatic Insufficiency; Metabolic Diseases; Central Nervous System Diseases; Nervous System Diseases; Liver Diseases; Brain Diseases, Metabolic; Hepatic Encephalopathy; Brain Diseases
• Other Study ID Numbers: 18-749

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No