Nutritional Interventions in Patients With Alcohol-associated Hepatitis

Launched by WESTERN UNIVERSITY, CANADA · Nov 8, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at how different types of nutrition can help people with severe alcoholic hepatitis, a serious liver condition that can be life-threatening. Researchers want to find out if giving patients extra nutrition through different methods—like regular food, enhanced food with extra fluids, or a special intravenous (IV) nutrition—can improve their health outcomes. This is important because many patients with this condition have low food intake, which is linked to higher chances of death. The goal is to find the best way to support these patients nutritionally during their hospital stay.

To be eligible for the trial, participants need to be adults over 18 who have been diagnosed with severe alcoholic hepatitis based on specific medical criteria. They should have been drinking heavily for at least five years and must have certain liver enzyme levels. However, people under 18, pregnant or breastfeeding women, and those with certain other health problems will not be able to participate. If someone joins the trial, they can expect to receive one of the three nutritional plans while being closely monitored by healthcare providers. This study could help doctors better understand how to care for patients with severe alcoholic hepatitis in the future.

Gender

ALL

Eligibility criteria

• 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.