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

Last updated: January 8, 2025
Sponsor: The Cleveland Clinic
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hepatic Encephalopathy

Vomiting

Arginase Deficiency

Treatment

Ensure Enlive

Standard Of Care

Clinical Study ID

NCT04096014
18-749
  • Ages 18-75
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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

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/dlfrom baseline that is unresponsive to withholding diuretics and intravenous albuminadministration (1 gm/kg up to 100 gm/day)

  • active malignancy

  • uncontrolled diabetes mellitus with A1c>9.5 (to avoid altered muscle proteinmetabolism

  • 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 Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Ensure Enlive
Phase:
Study Start date:
September 16, 2019
Estimated Completion Date:
October 30, 2026

Connect with a study center

  • Cleveland Clinic Foundation

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.