ADDUP: Alcohol Diet and Drug Use Preceding Alcoholic Hepatitis

Sponsor

University Hospital Birmingham (Other)

Overall Status

Unknown status

CT.gov ID

NCT02404636

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Alcohol use
Dietary intake
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	Phase
Hepatitis, Alcoholic	Other: Interview

Study Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Alcohol Diet and Drug Use Preceding Alcoholic Hepatitis

Study Start Date :

Jan 1, 2012

Anticipated Primary Completion Date :

Jan 1, 2018

Anticipated Study Completion Date :

Jan 1, 2018

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Changes in alcohol intake, dietary intake or drug use before illness [1 month]
Behavior before admission (Brief structured interview)

Secondary Outcome Measures

Survival after admission (Brief structured interview) [12 months]
Survival
Response to treatment (Brief structured interview) [1 week]
Response to treatment (corticosteroids, pentoxifylline or supportive medical care) after 1 week, measured by Lille score

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Queen Elizabeth Hospital Birmingham	Birmingham	West Midlands	United Kingdom	B15 2TH

Sponsors and Collaborators

University Hospital Birmingham

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Richard Parker, Clinical Lecturer, University Hospital Birmingham

ClinicalTrials.gov Identifier:

NCT02404636

Other Study ID Numbers:

RRK4357

First Posted:

Mar 31, 2015

Last Update Posted:

Apr 10, 2017

Last Verified:

Apr 1, 2017

Additional relevant MeSH terms:

Hepatitis A

Hepatitis

Hepatitis, Alcoholic

Study Results

No Results Posted as of Apr 10, 2017