Nutritional Interventions in Patients With Alcohol-associated Hepatitis

NCT ID: NCT06131177

Last Updated: 2024-05-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 2000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2025-12-31

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.

Conditions

Alcoholic Hepatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

Patients are treated with supplementary protein drink

Group Type: EXPERIMENTAL

Nutritional supplement

Intervention Type: DIETARY_SUPPLEMENT

Protein supplement

SOC (standard of Care)

Patient are provided normal hospital diet or meal

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Nutritional supplement

Protein supplement

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Western University, Canada

OTHER

Sponsor Role: lead

Responsible Party

Juan-Pablo Arab, MD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

13698

Identifier Type: -

Identifier Source: org_study_id