Alcohol Diet and Drug Use Preceding Alcoholic Hepatitis (ADDUP)

April 6, 2017 updated by: Richard Parker, University Hospital Birmingham

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • West Midlands
      • Birmingham, West Midlands, United Kingdom, B15 2TH
        • Queen Elizabeth Hospital Birmingham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients (aged over 18 years) admitted to Queen Elizabeth Hospital Birmingham, UK

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in alcohol intake, dietary intake or drug use before illness
Time Frame: 1 month
Behavior before admission (Brief structured interview)
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival after admission (Brief structured interview)
Time Frame: 12 months
Survival
12 months
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
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Anticipated)

January 1, 2018

Study Completion (Anticipated)

January 1, 2018

Study Registration Dates

First Submitted

March 26, 2015

First Submitted That Met QC Criteria

March 30, 2015

First Posted (Estimate)

March 31, 2015

Study Record Updates

Last Update Posted (Actual)

April 10, 2017

Last Update Submitted That Met QC Criteria

April 6, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RRK4357

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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