Status:
RECRUITING
Late Evening and Early Morning Protein Supplement to Reduce Readmissions for Hepatic Encephalopathy
Lead Sponsor:
The Cleveland Clinic
Conditions:
Hepatic Encephalopathy
Eligibility:
All Genders
18-75 years
Phase:
NA
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 ur...
Eligibility Criteria
Inclusion
- \> 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
- 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.
Key Trial Info
Start Date :
September 16 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 30 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04096014
Start Date
September 16 2019
End Date
October 30 2026
Last Update
November 25 2025
Active Locations (1)
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1
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195