Intensive Enteral Nutrition and Acute Alcoholic Hepatitis
Condition: Severe Alcoholic Hepatitis
MeSH terms: Hepatitis A; Hepatitis; Hepatitis, Alcoholic
Study type: Interventional

Summary: 
      To evaluate the effect of an intensive enteral nutrition (compared to clinical routine) in
      association with corticosteroïds in patients with severe acute alcoholic hepatitis.
    

Detailed description: 
      Acute alcoholic hepatitis (AAH) is characterized by hepatocellular necrosis, ballooning
      degeneration and an inflammatory reaction with many polymorphonuclear leukocytes, and
      fibrosis (Mezey E. Treatment of alcoholic liver disease. Semin Liver Dis 1993). The presence
      of a severe AAH was identified by the presence of a discriminant function (DF) ≥ 32. DF ≥ 32
      has been shown to prospectively identify patients with a 40 to 50 % risk of dying within 2
      months (Ramond et al, NEJM 1992). The main treatment of AAH consists of abstinence from
      alcohol. Corticosteroids are generally recommended in patients with severe AAH. Indeed, a
      recent analysis of the individual data of the patients from the last three randomized
      controlled trials showed a significantly higher 1-month survival in corticosteroids compared
      to placebo treated patients with a severe AAH (Mathurin et al, J hepatol 2002). However,
      efficacy of this therapy is insufficient, since around 40 % of patients with a severe AAH do
      not respond to corticosteroids (Louvet et al, Hepatology 2007). Moreover, corticosteroïds are
      still contraindicated in case of active infection or gastrointestinal bleeding, which are
      relatively common complications in those patients. Therefore, alternative therapeutic options
      are needed and must be a medical priority.

      Alcoholic patients with severe AAH are frequently malnourished and usually remain anorectic
      for several weeks (DiCecco SR et al, Nutr Clin Pract 2006). Some data indicate that
      malnutrition is a factor of bad prognosis in this disease. Recent evidence was also provided
      that adequate enteral nutritional support might have an important impact on long-term
      survival in those patients (Cabré et al, Hepatology 2000). However, up to now, no study
      evaluated potential synergetic effect of intensive enteral nutrition and corticosteroids.
      Moreover, in clinical practice, in the majority of the centers, patients with alcoholic
      hepatitis receive alimentary supplements and dietetic counseling, which is often insufficient
      and difficult to apply and to follow.

      Aim :

      To evaluate the effect of an intensive enteral nutrition (compared to clinical routine which
      consists in oral supplements) in association with corticosteroïds in patients with severe
      acute alcoholic hepatitis.
    

Intervention name(s): intensive nutrition; usual meals
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Patients randomized in " intensive enteral nutrition " arm will receive by feeding tube (with the use of a microsonde), and in continuous administration, 2 liters of Fresubin HP Energy (1500 kcal/liter, 75 gr prot/liter) for patients with a weight of more than 90 kgs (after ascites removal), 1.5 liters of Fresubin HP Energy for patients with a weight between 60 and 90 kgs, and 1 liter of Fresubin HP Energy for patients of less than 60 kgs. Patients with significant encephalopathy despite therapy against encephalopathy will receive Fresubin Hepa in place of Fresubin HP Energy (1300 kcal/liter, 40 gr prot/liter, 44 % branched AA). Duration of enteral nutrition by feeding tube will be 14 days. The adaptation to the targeted volume must be achieved in maximum 3 days. Enteral nutrition will be administered by nasogastric microsonde.; Patients randomized in " classical oral nutrition " arm (control arm) will receive usual meals (estimated at 1750 kcal/day; 70 g protein/day), and alimentary supplements between meals to achieve the ESPEN recommandations (35-40 kcal/kg/day; protein 1.2-1.5 g/kg/day) (Plauth et al, Clinical Nutrition 2006). Calories and proteins intake must be recorded daily.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment