Alcohol Diet and Drug Use Preceding Alcoholic Hepatitis

Hepatitis, Alcoholic Clinical Trial

— ADDUP  

Official title:

Alcohol Diet and Drug Use Preceding Alcoholic Hepatitis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02404636
• Other study ID #: RRK4357
• Status: Active, not recruiting
• Phase: N/A
• First received: March 26, 2015
• Last updated: April 6, 2017
• Start date: January 2012
• Est. completion date: January 2018

Study information

• Verified date: April 2017
• Source: University Hospital Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis, Alcoholic

Intervention

Other:
• Interview
Brief structured interview

Locations

Country	Name	City	State
United Kingdom	Queen Elizabeth Hospital Birmingham	Birmingham	West Midlands

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Birmingham

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in alcohol intake, dietary intake or drug use before illness	Behavior before admission (Brief structured interview)	1 month
Secondary	Survival after admission (Brief structured interview)	Survival	12 months
Secondary	Response to treatment (Brief structured interview)	Response to treatment (corticosteroids, pentoxifylline or supportive medical care) after 1 week, measured by Lille score	1 week