Alcohol Diet and Drug Use Preceding Alcoholic Hepatitis

NCT02404636 | Unknown

• 1 other identifier: RRK4357
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

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

Conditions

Hepatitis, Alcoholic

Outcome Measures

Primary Outcomes (1)

• Changes in alcohol intake, dietary intake or drug use before illness

  Behavior before admission (Brief structured interview)

  1 month

Secondary Outcomes (2)

• Survival after admission (Brief structured interview)

  12 months

• Response to treatment (Brief structured interview)

  1 week

Study Arms (2)

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

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

Interventions

Interview OTHER

Brief structured interview

Alcoholic hepatitis; Hazardous alcohol use

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital Birmingham: lead

Study Sites (1)

Queen Elizabeth Hospital Birmingham

Birmingham, West Midlands, B15 2TH, United Kingdom

Location

MeSH Terms

Conditions

Hepatitis, Alcoholic

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Hepatitis; Liver Diseases; Digestive System Diseases; Liver Diseases, Alcoholic; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Lecturer

Study Record Dates

• First Submitted: March 26, 2015
• First Posted: March 31, 2015
• Study Start: January 1, 2012
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: April 10, 2017

Record last verified: 2017-04

Locations

GB (1)