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

Status: Recruiting
Location: See location...
Intervention Type: Other, Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• \> 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

Locations
United States
Ohio
Cleveland Clinic Foundation
RECRUITING
Cleveland
Contact Information
Primary
Annette C Bellar
bellara@ccf.org
2166365247
Time Frame
Start Date: 2019-09-16
Estimated Completion Date: 2026-10-30
Participants
Target number of participants: 40
Treatments
Active_comparator: Ensure Enlive
Placebo_comparator: Standard of Care
Related Therapeutic Areas
Sponsors
Leads: The Cleveland Clinic

This content was sourced from clinicaltrials.gov