Nutritional Interventions in Patients With Alcohol-associated Hepatitis

Study Overview
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Brief Summary
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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.

Official Title
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Comparing Nutritional Interventions in Patients With Alcohol-associated Hepatitis: a Randomized Controlled Trial

Conditions
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Alcoholic Hepatitis

Intervention / Treatment
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* Dietary Supplement: Nutritional supplement


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Adult (>18 years) patients admitted with acute severe AH based clinical diagnosis according to NIAAA criteria Excessive alcohol consumption for more than 5 years in a row or interrupted No more than 60 days of abstinence before the onset of jaundice Bilirubin levels >3 mg/dL (>50 umol/L), AST>50 IU/mL, AST/ALT ratio > 1.5 Abstinence of other causes of liver disease MELD score ≥ 20 Exclusion criteria: Age < 18 years Pregnancy or lactation. Allergy or intolerance to the enhanced oral intake formulation or PPN formulation. Expected length of stay less than 48 hours. Contraindications to IV fluid or PPN administration (fluid overload, suspected bacteremia). Presence of drug-induced liver injury (DILI), ischemic hepatitis, biliary duct obstruction, viral hepatitis, autoimmune hepatitis, or Wilson's disease. Extrahepatic neoplasia with a life expectancy of less than 6 months. History of severe extrahepatic disease (e.g., chronic kidney failure requiring hemodialysis, severe heart disease (NYHA class ≥3), severe chronic lung disease (class ORO ≥3) that confers a survival of less than 6 months.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Patients are treated with supplementary protein drink | Dietary Supplement: Nutritional supplement<br>* Protein supplement<br>|
| No Intervention: SOC (standard of Care)<br>Patient are provided normal hospital diet or meal | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transplant free survival (30 days) | 30 days mortality (%) | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transplant free survival (90 days) | 90 day mortality (%) | 90 days |