Procalcitonin in Cirrhotic Patients at High Risk for Sepsis

Completed

• Conditions: Sepsis; Ascites; Cirrhosis

• Registration Number: NCT01578226
• Lead Sponsor: Prof. Facchinetti Fabio

Brief Summary

Infections are frequent life-threatening events in patients with cirrhosis, occurring at least in 35% of hospitalized patients and accounting for 20% of inpatients death. Among cirrhotics, ascitic patients have the highest risk of death for sepsis. At the admission, no clear-cut clinical and biochemical features are helpful in diagnosing and prognostically stratifying those patients with sepsis. Procalcitonin (PCT)is a breakthrough marker presenting high sensibility and specificity in diagnosing bacterial infections in different clinical settings. The purpose of this study is to evaluate PCT as a diagnostic and prognostic tool for sepsis in hospitalized cirrhotic patients with ascitic decompensation.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Primary Completion: 2010-09
• Study Completion: 2011-09
• Status Verified: 2012-04
• Study First Submitted: 2012-04-13
• Study First Submitted QC: 2012-04-13
• Last Update Submitted: 2012-04-13
• Study First Posted: 2012-04-16
• Last Update Posted: 2012-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• liver cirrhosis regardless of aetiology
• clinically relevant ascitic decompensation at time of hospital admission

Exclusion Criteria

• high haematic ascites
• ongoing antimicrobial therapy or stopped less than 7 days before admission
• last hospital discharge within 7 days
• surgery or trauma within 30 days from enrolment
• hepatocellular carcinoma out of Milan criteria
• extra hepatic malignancies
• immunodeficiency syndrome
• pregnancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Gastroenterology Unit - University Hospital of Modena; 🇮🇹 Modena, Italy