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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ensure Enlive | Active Comparator |
| |
| Standard of Care | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ensure Enlive | Dietary Supplement | The subjects in the intervention group will receive two Ensure Enlive supplements per day for 180 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Determine if decreasing nocturnal fasting by protein supplements will change readmission rates. | Change in number of readmissions | Day 0 & Day 180 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Annette C Bellar | Contact | 2166365247 | 2166365247 | bellara@ccf.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Foundation | Recruiting | Cleveland | Ohio | 44195 | United States |
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| ID | Term |
|---|---|
| D006501 | Hepatic Encephalopathy |
| ID | Term |
|---|---|
| D017093 | Liver Failure |
| D048550 | Hepatic Insufficiency |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard Of Care | Other | The subjects in the Standard of care group will continue to receive the standard clinical therapy. |
|
| D001928 |
| Brain Diseases, Metabolic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |