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NCT04096014 · ClinicalTrials.gov registry record · NA
Late Evening and Early Morning Protein Supplement to Reduce Readmissions for Hepatic Encephalopathy
A NA study of Hepatic Encephalopathy, sponsored by The Cleveland Clinic.
- Recruiting
- Registry status
- NA
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT04096014: Recruiting NA study of Hepatic Encephalopathy, sponsored by The Cleveland Clinic.
NCT04096014 is a NA study of Hepatic Encephalopathy that is actively recruiting participants, run by The Cleveland Clinic. The registered enrollment target is 40 participants, below the 173-participant average among 12 other Hepatic Encephalopathy trials with a reported enrollment target (77% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04096014, a NA study of Hepatic Encephalopathy, is actively recruiting participants, sponsored by The Cleveland Clinic.
- RECRUITING
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Change in number of readmissions
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Ensure Enlive
- OTHER Standard Of Care
Study Locations (1)
Ohio
- Cleveland Clinic Foundation - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2019-09-16 |
| Est. Completion | 2026-10-30 |
| Phase | NA |
What NCT04096014 shows while recruiting
NCT04096014 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 173-participant average among 12 other Hepatic Encephalopathy trials with a reported enrollment target (77% lower).
The record links to 1 condition, with Hepatic Encephalopathy appearing as the primary indexed condition, and to 2 interventions - of which Ensure Enlive is the first listed.
NCT04096014 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT04096014 about?
NCT04096014 is a clinical study titled "Late Evening and Early Morning Protein Supplement to Reduce Readmissions for Hepatic Encephalopathy". 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 in...
What is the current status of trial NCT04096014?
This trial is currently recruiting. It is a NA study. The enrollment target is 40 participants. The study started on 2019-09-16. Estimated completion is 2026-10-30.
What conditions does trial NCT04096014 study?
This clinical trial studies the following conditions: Hepatic Encephalopathy.
What interventions are being tested in trial NCT04096014?
The interventions under investigation include: Ensure Enlive (DIETARY_SUPPLEMENT), Standard Of Care (OTHER).
Who is sponsoring clinical trial NCT04096014?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04096014 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hepatic Encephalopathy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04096014's enrollment target sits among peer trials
40 9th of 12 higher than 4 of 12 other Hepatic Encephalopathy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hepatic Encephalopathy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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