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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04096014
The ClinicalTrials.gov registry entry for NCT04096014 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 173-participant average among 12 other Hepatic Encephalopathy trials with a reported enrollment target (77% lower). The listed sponsor is The Cleveland Clinic, which has 688 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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