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

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Jun 30, 2026 → Jun 30, 2027
See other at-risk trials from The Cleveland Clinic

Record History

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  1. Primary completion pushed from Jun 30, 2026 to Jun 30, 2027
    • Study completion pushed from Oct 30, 2026 to Oct 30, 2028
    • Eligibility criteria expanded, about 13 words
  2. 2 versions Re-verified since Jan 8, 2025, no change to tracked fieldsv8-v9
  3. Primary completion date: Jun 30, 2024 to Jun 30, 2026
    • Study completion date: Oct 30, 2024 to Oct 30, 2026
    v7
  4. Primary completion date: Jun 30, 2023 to Jun 30, 2024
    • Study completion date: Oct 30, 2023 to Oct 30, 2024
    v6
  5. Primary completion date: Jun 30, 2022 to Jun 30, 2023v5
Show 3 earlier versionsHide 3 earlier versions
  1. Re-verified, no change to tracked fieldsv4
  2. Primary completion date: Jun 30, 2020 to Jun 30, 2022
    • Study completion date: Oct 30, 2020 to Oct 30, 2023
    v3
  3. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04096014
Lead Sponsor The Cleveland Clinic
Conditions
(from sponsor)		 Hepatic Encephalopathy
Related terms Hepatic Encephalopathy
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov