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

Not Applicable

Recruiting

• Conditions: Hepatic Encephalopathy
• Interventions: Dietary Supplement: Ensure Enlive; Other: Standard Of Care

• Registration Number: NCT04096014
• Lead Sponsor: The Cleveland Clinic

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-11
• Study Start: 2019-09-16
• Study First Submitted QC: 2019-09-17
• Study First Posted: 2019-09-19
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-08
• Last Update Posted: 2025-01-10
• Primary Completion: 2026-06-30
• Study Completion: 2026-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ensure Enlive	Standard Of Care	-
Standard of Care	Standard Of Care	-
Ensure Enlive	Ensure Enlive	-

Primary Outcome Measures

Name	Time	Method
Determine if decreasing nocturnal fasting by protein supplements will change readmission rates.	Day 0 & Day 180	Change in number of readmissions

Trial Locations

Locations (1)

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States