Status:
NOT_YET_RECRUITING
Nutritional Interventions in Patients With Alcohol-associated Hepatitis
Lead Sponsor:
Western University, Canada
Conditions:
Alcoholic Hepatitis
Eligibility:
All Genders
18+ years
Phase:
NA
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 (...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
January 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT06131177
Start Date
January 1 2025
End Date
December 31 2025
Last Update
May 29 2024
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