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

Description

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.

Conditions

Hepatic Encephalopathy

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Study Overview

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Study Details

Study 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.

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

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

Condition
Hepatic Encephalopathy
Intervention / Treatment

-

Contacts and Locations

Cleveland

Cleveland Clinic Foundation, Cleveland, Ohio, United States, 44195

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

The Cleveland Clinic,

Study Record Dates

2026-10-30