Procalcitonin in Cirrhotic Patients at High Risk for Sepsis

NCT01578226 | Completed

• 1 other identifier: PCTCIRR
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Cirrhosis; Ascites; Sepsis

Keywords

Cirrhosis; Ascites; Decompensation; Bacterial infection; Sepsis; Procalcitonin; PCT

Study Arms (1)

Decompensated cirrhotic patients

Cirrhotic patients presenting with clinically detectable ascites (Grade 2 o Grade 3)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All ascitic cirrhotic patients admitted to our third level Liver Unit.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prof. Facchinetti Fabio: lead

Study Sites (1)

Gastroenterology Unit - University Hospital of Modena

Modena, 41124, Italy

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Fibrosis; Ascites; Sepsis; Bacterial Infections

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Bacterial Infections and Mycoses

Study Officials

• Filippo Schepis, MD

  University of Modena and Reggio Emilia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PRS Admin

Study Record Dates

• First Submitted: April 13, 2012
• First Posted: April 16, 2012
• Study Start: October 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2011
• Last Updated: April 16, 2012

Record last verified: 2012-04

Locations

IT (1)