Clinical trial NCT05883891: Prothrombin Time Predicts Steroid Response in Severe Alcoholic Hepatitis.
Official title: Prothrombin Time Predicts Steroid Response in Severe Alcoholic Hepatitis.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alcoholic Hepatitis
Keywords: early liver transplantation
alcohol
cirrhosis
corticosteroid therapy
Maddrey's discriminant function
Lille score
prothrombin time
Alcohol Use Disorder
steroid response
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-06-01
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to the Internal Medicine and Alcohol Related Diseases Unit of a teaching hospital with a clinical diagnosis of severe alcoholic hepatitis

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).


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.

Primary outcomes:
measure: response to steroid treatment
timeFrame: seven days
Secondary outcomes:
measure: death
timeFrame: 28 days
measure: early liver transplantation
timeFrame: 7 days
measure: infection
timeFrame: 28 days
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Agostino Gemelli Polyclinic
state: Roma (provincia)
Study officials:
affiliation: Internal Medicine and Alcohol Related Disease Unit, Department of Medical and Surgical Sciences, Columbus-Gemelli Hospital, Fondazione Policlinico Universitario A. Gemelli IRCCS, Catholic University of Rome, Rome, Italy
name: Giovanni Addolorato
role: PRINCIPAL_INVESTIGATOR
References: