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Alcohol-associated hepatitis (AH) is a life-threatening condition with high 90-days mortality (up to 40%) and limited treatment options. Previous studies have shown that decreased nutritional intake (less than 21 kcal/kg/day) is associated to a higher mortality compared to patients with a higher caloric intake. Additionally, it has been suggested that subjects with severe AH, should receive a high-protein diet, however, no specific trials have been carried out to address these questions. Thus, the investigators aim to compare nutritional interventions through a randomized controlled trial to assess if a strategy of peripheral parental nutrition (PPN) plus oral nutritional supplementation (ONS) improves outcomes in patients with severe AH. The investigators will compare standard oral intake, enhanced oral intake with IV fluid supplementation, and PPN plus ONS in patients admitted to hospital with severe AH. These results potentially will help guide practitioners on caloric benchmarks targets for patients with severe AH. This study will also assess specific risks and benefits of different nutritional interventions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Patients are treated with supplementary protein drink |
|
| SOC (standard of Care) | No Intervention | Patient are provided normal hospital diet or meal |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutritional supplement | Dietary Supplement | Protein supplement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Transplant free survival (30 days) | 30 days mortality (%) | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Transplant free survival (90 days) | 90 day mortality (%) | 90 days |
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Inclusion criteria:
Exclusion criteria:
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| ID | Term |
|---|---|
| D006519 | Hepatitis, Alcoholic |
| ID | Term |
|---|---|
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D008108 | Liver Diseases, Alcoholic |
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| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| D020751 |
| Alcohol-Induced Disorders |
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |