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

Hepatic Encephalopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04096014
• Other study ID #: 18-749
• Status: Recruiting
• Phase: N/A
• Start date: September 16, 2019
• Est. completion date: October 30, 2026

Study information

• Verified date: May 2024
• Source: The Cleveland Clinic
• Contact: Annette C Bellar
• Phone: 2166365247
• Email: bellara[@]ccf.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Diseases
• Hepatic Encephalopathy

Intervention

Dietary Supplement:
• Ensure Enlive
The subjects in the intervention group will receive two Ensure Enlive supplements per day for 180 days.

Other:
• Standard Of Care
The subjects in the Standard of care group will continue to receive the standard clinical therapy.

Locations

Country	Name	City	State
United States	Cleveland Clinic Foundation	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine if decreasing nocturnal fasting by protein supplements will change readmission rates.	Change in number of readmissions	Day 0 & Day 180