Prothrombin Time Predicts Steroid Response in Severe Alcoholic Hepatitis.

Completed

• Conditions: Alcoholic Hepatitis

• Registration Number: NCT05883891
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief Summary

Alcoholic hepatitis (AH) is the most severe form of acute alcohol-related liver disease. Maddrey's discriminant function (mDF) \>32 defines the severe form of AH, which is associated with a high mortality. Corticosteroid therapy (CS) represents the main medical treatment that may reduce short-term mortality. Lille score at day 7 assesses the therapeutic response to steroid therapy. At present, no parameters able to predict the response to steroid therapy have been highlighted. The mDF depends mainly on prothrombin time (PT). Aim of the present study was to evaluate if the PT value could predict the response to CS in severe AH (sAH).

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-01
• Primary Completion: 2022-09-30
• Study Completion: 2022-11-30
• Status Verified: 2023-05
• Study First Submitted: 2023-05-22
• Study First Submitted QC: 2023-05-22
• Last Update Submitted: 2023-05-22
• Study First Posted: 2023-06-01
• Last Update Posted: 2023-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• clinical diagnosis of first episode of severe alcoholic hepatitis with Maddrey's function score of 32 or higher, and the absence of contraindication to CS therapy (non-controlled infections/sepsis, hepatic encephalopathy, recent acute gastrointestinal bleeding, severe kidney dysfunction). The diagnosis of AH was based on the criteria of the National Institute on Alcohol Abuse and Alcoholism (NIAAA)-funded Alcoholic Hepatitis Consortia (Crabb DW, 2016). In particular, were enrolled in the study patients with: heavy alcohol use for >6 months, with an average consumption of more than 3 drinks (∼40 g) per day for women and 4 drinks (∼50-60 g) per day for men and with <30 days of abstinence before the onset of jaundice; AST/ALT ratio > 1.5 with an AST level > 45 IU/L (1.5 times upper limit of normal) and < 400 IU/L; serum bilirubin >3 mg/dL.

Exclusion Criteria

• acute or chronic viral hepatitis,
• nonalcoholic steatohepatitis,
• cocaine use,
• drug-induced liver injury,
• fulminant Wilsons disease,
• hepatocellular carcinoma,
• portal vein thrombosis,
• biliary obstruction,
• severe autoimmune liver disease,
• neoplasms,
• severe comorbidities.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
response to steroid treatment	seven days	response to standard medical treatment assessed with Lille scoremat day 7

Secondary Outcome Measures

Name	Time	Method
death	28 days	death occurring during hospitalization from any cause
early liver transplantation	7 days	early transplantation in case of failure of medical treatment
infection	28 days	occurrence of opportunistic infections following steroid treatment

Trial Locations

Locations (1)

Agostino Gemelli Polyclinic; 🇮🇹 Rome, Roma (provincia), Italy