RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2019-09-16
Study Completion:2026-10-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04096014

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.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * \> 18 years of age
  2. * cirrhosis diagnosed by clinical history and liver biopsy and/or clinical, biochemical and imaging evidence of cirrhosis
  3. * at least 1 hospitalization for documented HE within the last 12 months.
  4. * abdominal CT scan anytime in the past
  1. * Patients with MELD score \> 35
  2. * end stage organ failure (major dysfunction requiring organ support)
  3. * 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)
  4. * active malignancy
  5. * uncontrolled diabetes mellitus with A1c\>9.5 (to avoid altered muscle protein metabolism
  6. * medications (anabolic steroids, corticosteroids) that affect skeletal muscle mass
  7. * recent gastrointestinal surgery within past 12 months
  8. * ongoing infection (positive blood or other body fluid cultures)
  9. * active gastrointestinal bleeding.

Contacts and Locations

Study Contact

Annette C Bellar
CONTACT
2166365247
bellara@ccf.org

Study Locations (Sites)

Cleveland Clinic Foundation
Cleveland, Ohio, 44195
United States

Collaborators and Investigators

Sponsor: The Cleveland Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-09-16
Study Completion Date2026-10-30

Study Record Updates

Study Start Date2019-09-16
Study Completion Date2026-10-30

Terms related to this study

Additional Relevant MeSH Terms

  • Hepatic Encephalopathy