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Trial record 40 of 126 for:    "Viral Infectious Disease" | "Ethanol"

Alcohol Diet and Drug Use Preceding Alcoholic Hepatitis (ADDUP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02404636
Recruitment Status : Unknown
Verified April 2017 by Richard Parker, University Hospital Birmingham.
Recruitment status was:  Active, not recruiting
First Posted : March 31, 2015
Last Update Posted : April 10, 2017
Information provided by (Responsible Party):
Richard Parker, University Hospital Birmingham

Brief Summary:

ADDUP is an observational study of patients with alcoholic hepatitis. A structured interview is used to quantitatively estimate:

  1. Alcohol use
  2. Dietary intake
  3. Drug use (legal and illegal)

in the weeks preceding onset of acute alcoholic hepatitis. After interview patients are followed up for 12 months with regard to response to therapy and survival.

The study is intended to explore potential precipitants of alcoholic hepatitis.

Condition or disease Intervention/treatment
Hepatitis, Alcoholic Other: Interview

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Alcohol Diet and Drug Use Preceding Alcoholic Hepatitis
Study Start Date : January 2012
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Alcoholic hepatitis
Individuals admitted to hospital with acute alcoholic hepatitis, defined as acute onset of jaundice in the context of recent hazardous alcohol use and the absence of other liver disease
Other: Interview
Brief structured interview

Hazardous alcohol use
Individuals admitted to hospital for any cause who drink hazardous quantities of alcohol but without evidence of alcoholic hepatitis or advanced liver disease
Other: Interview
Brief structured interview

Primary Outcome Measures :
  1. Changes in alcohol intake, dietary intake or drug use before illness [ Time Frame: 1 month ]
    Behavior before admission (Brief structured interview)

Secondary Outcome Measures :
  1. Survival after admission (Brief structured interview) [ Time Frame: 12 months ]

  2. Response to treatment (Brief structured interview) [ Time Frame: 1 week ]
    Response to treatment (corticosteroids, pentoxifylline or supportive medical care) after 1 week, measured by Lille score

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients (aged over 18 years) admitted to Queen Elizabeth Hospital Birmingham, UK

Inclusion Criteria:

  • acute alcoholic hepatitis
  • aged over 18 years
  • able to give informed consent

Exclusion Criteria:

  • evidence of other acute or chronic liver disease
  • episode of alcoholic hepatitis in 6 months before admission
  • severe hepatic encephalopathy
  • delirium

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02404636

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United Kingdom
Queen Elizabeth Hospital Birmingham
Birmingham, West Midlands, United Kingdom, B15 2TH
Sponsors and Collaborators
University Hospital Birmingham

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Responsible Party: Richard Parker, Clinical Lecturer, University Hospital Birmingham Identifier: NCT02404636     History of Changes
Other Study ID Numbers: RRK4357
First Posted: March 31, 2015    Key Record Dates
Last Update Posted: April 10, 2017
Last Verified: April 2017
Additional relevant MeSH terms:
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Virus Diseases
RNA Virus Infections
Hepatitis A
Hepatitis, Alcoholic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
Liver Diseases, Alcoholic
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs