Nutritional Interventions in Patients With Alcohol-associated Hepatitis
- Conditions
- Alcoholic Hepatitis
- Interventions
- Dietary Supplement: Nutritional supplement
- Registration Number
- NCT06131177
- Lead Sponsor
- Western University, Canada
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 2000
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment Nutritional supplement Patients are treated with supplementary protein drink
- Primary Outcome Measures
Name Time Method Transplant free survival (30 days) 30 days 30 days mortality (%)
- Secondary Outcome Measures
Name Time Method Transplant free survival (90 days) 90 days 90 day mortality (%)