Diagnostic performance of procalcitonin for diagnosis of bacterial infection in severe alcoholic hepatitis

Not Applicable

Conditions: Diseases of the digestive system

Registration Number: KCT0004627

Lead Sponsor: Inje University Haeundae Paik Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot yet recruiting

Sex: All

Target Recruitment: 108

Inclusion Criteria

In case that the below three conditions are fulfilled
1) Age : 19 years old or more
2) Chronic alcohol intake (WHO harmful drinking criteria): Male >60 g/day, Female > 40 g/day
3) Abnormal liver function
a. Total bilirubin = 5 mg/dL
b. AST 40~500 U/L
c. ALT <200 U/L
d. AST/ALT >2
4) Modified Maddrey discriminant function (mMDF) score = 32
*mMDF = 4.6× [PTpatient – PTcontrol] (sec) + total bilirubin (mg/dL)

Exclusion Criteria

Any one of the below conditions
1) Persistent jaundice over 3 months
2) Recent abstinence period over 2 months
3) Acute or chronic viral hepatitis (HAV, HBV, HCV)
4) Autoimmune hepatitis
5) Neoplasm including hepatocellualr carcinoma
6) Toxic hepatitis or drug-induced liver injury
7) Acute pancreatitis
8) Gastrointestinal bleeding
9) Acute cholecystitis or cholangitis

Study & Design

Study Type: Observational Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy of procalcitonin for bacterial infection in severe acloholic hepatitis (c-statistics)

Secondary Outcome Measures

Name	Time	Method
Diagnostic accuracy of c-reactive protein for bacterial infection in severe acloholic hepatitis (c-statistics);Diagnostic accuracy of procalcitonin and c-reactive protein for SIRS in severe acloholic hepatitis (c-statistics);Diagnostic accuracy of procalcitonin and c-reactive protein for sepsis in severe acloholic hepatitis (c-statistics)