Back to resultsLate Evening and Early Morning Protein Supplement to Reduce Readmissions for Hepatic Encephalopathy
Primary Purpose
Hepatic Encephalopathy
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ensure Enlive
Standard Of Care
Sponsored by
About this trial
This is an interventional prevention trial for Hepatic Encephalopathy
Eligibility Criteria
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.
Sites / Locations
- Cleveland Clinic FoundationRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Ensure Enlive
Standard of Care
Arm Description
Outcomes
Primary Outcome Measures
Determine if decreasing nocturnal fasting by protein supplements will change readmission rates.
Change in number of readmissions
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04096014
Brief Title
Late Evening and Early Morning Protein Supplement to Reduce Readmissions for Hepatic Encephalopathy
Official Title
Late Evening and Early Morning Protein Supplement to Reduce Readmissions for Hepatic Encephalopathy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 16, 2019 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
October 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Encephalopathy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ensure Enlive
Arm Type
Active Comparator
Arm Title
Standard of Care
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Ensure Enlive
Intervention Description
The subjects in the intervention group will receive two Ensure Enlive supplements per day for 180 days.
Intervention Type
Other
Intervention Name(s)
Standard Of Care
Intervention Description
The subjects in the Standard of care group will continue to receive the standard clinical therapy.
Primary Outcome Measure Information:
Title
Determine if decreasing nocturnal fasting by protein supplements will change readmission rates.
Description
Change in number of readmissions
Time Frame
Day 0 & Day 180
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Annette C Bellar
Phone
2166365247
Ext
2166365247
Email
bellara@ccf.org
Facility Information:
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Annette Bellar, BS
Phone
216-445-6268
Email
bellara@ccf.org
First Name & Middle Initial & Last Name & Degree
Revathi Penumatsa
Email
penumar@ccf.org
First Name & Middle Initial & Last Name & Degree
Srinivasan Dasarathy, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Late Evening and Early Morning Protein Supplement to Reduce Readmissions for Hepatic Encephalopathy
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