Prothrombin Time Predicts Steroid Response in Severe Alcoholic Hepatitis.

Study Overview
=================
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).

Official Title
-----------------
Prothrombin Time Predicts Steroid Response in Severe Alcoholic Hepatitis.

Conditions
-----------------
Alcoholic Hepatitis

Intervention / Treatment
-----------------
* Diagnostic Test: prothrombin time


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| severe alcoholic hepatitis<br>Patients admitted with a clinical diagnosis of severe alcoholic hepatitis eligible to corticosteroid treatment. Prothrombin time at diagnosis was registered to evaluate wether it correlated with Lille score at day 7 and therefore response to standard medical treatment. | Diagnostic Test: prothrombin time<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| response to steroid treatment | response to standard medical treatment assessed with Lille scoremat day 7 | seven days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| death | death occurring during hospitalization from any cause | 28 days | 
| early liver transplantation | early transplantation in case of failure of medical treatment | 7 days | 
| infection | occurrence of opportunistic infections following steroid treatment | 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
early liver transplantation, alcohol, cirrhosis, corticosteroid therapy, Maddrey's discriminant function, Lille score, prothrombin time, Alcohol Use Disorder, steroid response