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

Sponsor

The Cleveland Clinic (Other)

Overall Status

Recruiting

CT.gov ID

NCT04096014

Collaborator

(none)

Enrollment

Location

Arms

49.4

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatic Encephalopathy	Dietary Supplement: Ensure Enlive Other: Standard Of Care	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Sep 16, 2019

Anticipated Primary Completion Date :

Jun 30, 2022

Anticipated Study Completion Date :

Oct 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Ensure Enlive	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.
Placebo Comparator: Standard of Care	Other: Standard Of Care The subjects in the Standard of care group will continue to receive the standard clinical therapy.

Arm

Intervention/Treatment

Active Comparator: Ensure Enlive

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.

Placebo Comparator: Standard of Care

Other: Standard Of Care

The subjects in the Standard of care group will continue to receive the standard clinical therapy.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195

Sponsors and Collaborators

The Cleveland Clinic

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Srinivasan Dasarathy, Staff Physician, The Cleveland Clinic

ClinicalTrials.gov Identifier:

NCT04096014

Other Study ID Numbers:

18-749

First Posted:

Sep 19, 2019

Last Update Posted:

Aug 20, 2021

Last Verified:

Aug 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hepatic Encephalopathy

Brain Diseases

Study Results

No Results Posted as of Aug 20, 2021