NCT01801332

Brief 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.

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
136

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
2 countries

19 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

February 27, 2013

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 28, 2013

Completed
Last Updated

February 28, 2013

Status Verified

February 1, 2013

Enrollment Period

3 years

First QC Date

February 27, 2013

Last Update Submit

February 27, 2013

Conditions

Severe Alcoholic Hepatitis

Outcome Measures

Primary Outcomes (1)

  • survival

    6 months survival

Secondary Outcomes (1)

  • survival

    1 month

Other Outcomes (1)

  • infection rate during hospitalisation, early bilirubin change (day 7), Lille score, development of hepatorenal syndrome

    entire study duration (6 months)

Study Arms (2)

intensive arm

EXPERIMENTAL

Corticosteroïds (Methylprednisolone 32 mg/d) for 28 days + intensive enteral nutrition by feeding tube for 14 days

Dietary Supplement: intensive nutrition

control arm

ACTIVE COMPARATOR

Corticosteroïds (Methylprednisolone 32 mg/d) for 28 days + " classical " oral alimentation for 14 days

Dietary Supplement: usual meals

Interventions

intensive nutritionDIETARY_SUPPLEMENT

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.

intensive arm
usual mealsDIETARY_SUPPLEMENT

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.

control arm

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Acute alcoholic hepatitis proven by a liver biopsy (necessary histological findings : neutrophils infiltration, ballooned hepatocytes and Mallory bodies)
  • Presence of a severe disease, defined by a Maddrey score higher than or equal to 32, at screening and in baseline (day 0). Maddrey score = total bilirubin in mg/dl + 4,6 X (Prothrombin time patient in sec - prothrombin time control in sec)
  • Age between 18 and 75 years old, extremes included
  • Recent jaundice or in recent aggravation (less than 3 months)
  • Chronic alcohol consumption (more than 40 g/day)
  • Informed consent read, understand and signed by the patient (in case of significant encephalopathy, a family representative can signed in place of the patient)
  • Maximal delay between admission and randomization of 14 days.

You may not qualify if:

  • Other disease compromising 6 months survival of the patient
  • Positive HIV or HCV serology, positive HBs Antigen
  • Uncontrolled bacterial or fungal infection (infection must be judged controlled for at least 3 days)
  • Uncontrolled upper GI bleeding (bleeding must be controlled for at least 5 days)
  • Type 1 Hepatorenal syndrome (creatinin upper than 2,5 mg/dl), as defined by Salerno F et al, Gut 2007;56:1310-1318
  • History of bariatric surgery
  • Pentoxyphilline therapy
  • MARS therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

UZ Antwerpen

Antwerp, Belgium

Location

AZ Brugge

Bruges, Belgium

Location

CHU Saint-Pierre

Brussels, 1000, Belgium

Location

CHU Brugmann

Brussels, 1020, Belgium

Location

Erasme University Hospital

Brussels, 1070, Belgium

Location

AZ VUB

Brussels, 1090, Belgium

Location

Cliniques universitaires Saint-Luc

Brussels, Belgium

Location

Hôpitaux Iris-Sud

Brussels, Belgium

Location

UZ Gent

Ghent, Belgium

Location

Hôpital de Jolimont

La Louvière, Belgium

Location

KU Leuven

Leuven, Belgium

Location

CHR La Citadelle

Liège, Belgium

Location

Hôpital Saint-Joseph

Liège, Belgium

Location

ULG Sart Tilman

Liège, Belgium

Location

CHR Saint Joseph-Warquignies

Mons, Belgium

Location

Hôpital Ambroise Paré

Mons, Belgium

Location

Hôpital Ottignies

Ottignies-Louvain-la-Neuve, Belgium

Location

CHU Caen

Caen, France

Location

CHU Lille

Lille, France

Location

Related Publications (1)

  • Moreno C, Deltenre P, Senterre C, Louvet A, Gustot T, Bastens B, Hittelet A, Piquet MA, Laleman W, Orlent H, Lasser L, Serste T, Starkel P, De Koninck X, Negrin Dastis S, Delwaide J, Colle I, de Galocsy C, Francque S, Langlet P, Putzeys V, Reynaert H, Degre D, Trepo E. Intensive Enteral Nutrition Is Ineffective for Patients With Severe Alcoholic Hepatitis Treated With Corticosteroids. Gastroenterology. 2016 Apr;150(4):903-10.e8. doi: 10.1053/j.gastro.2015.12.038. Epub 2016 Jan 5.

    PMID: 26764182DERIVED

MeSH Terms

Conditions

Hepatitis, Alcoholic

Condition Hierarchy (Ancestors)

HepatitisLiver DiseasesDigestive System DiseasesLiver Diseases, AlcoholicAlcohol-Induced DisordersAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced Disorders

Study Officials

  • Christophe Moreno, MD, PhD

    Erasme University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical director of the liver unit, Department of Gastroenterology, Hepatopancreatology and Digestive oncology

Study Record Dates

First Submitted

February 27, 2013

First Posted

February 28, 2013

Study Start

February 1, 2010

Primary Completion

February 1, 2013

Last Updated

February 28, 2013

Record last verified: 2013-02

Locations

FR(2)BE(17)