Prothrombin Time Predicts Steroid Response in Severe Alcoholic Hepatitis.

Alcoholic Hepatitis Clinical Trial

— AH2023  

Official title:

Prothrombin Time Predicts Steroid Response in Severe Alcoholic Hepatitis.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05883891
• Other study ID #: 5840
• Status: Completed
• Start date: June 1, 2017
• Est. completion date: November 30, 2022

Study information

• Verified date: May 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: November 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alcoholic Hepatitis
• Hepatitis
• Hepatitis A
• Hepatitis, Alcoholic

Intervention

Diagnostic Test:
• prothrombin time
Prothrombin time at value at diagnosis was used to assess the presence of a correlation with Lille score at day 7 and therefore wether it could predict response to medical treatment.

Locations

Country	Name	City	State
Italy	Agostino Gemelli Polyclinic	Rome	Roma (provincia)

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	response to steroid treatment	response to standard medical treatment assessed with Lille scoremat day 7	seven days
Secondary	death	death occurring during hospitalization from any cause	28 days
Secondary	early liver transplantation	early transplantation in case of failure of medical treatment	7 days
Secondary	infection	occurrence of opportunistic infections following steroid treatment	28 days