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NCT01578226 Clinical Trial

Procalcitonin in Cirrhotic Patients at High Risk for Sepsis

Sepsis Clinical Trial

Official title:
Role of Procalcitonin (PCT) for the Diagnosis of Sepsis in Ascitic Cirrhotic Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01578226
Other study ID # PCTCIRR
Secondary ID
Status Completed
Phase N/A
First received April 13, 2012
Last updated April 13, 2012
Start date October 2009
Est. completion date September 2011

Study information
Verified date April 2012
Source University of Modena and Reggio Emilia
Contact n/a
Is FDA regulated No
Health authority Italy: Ethics CommitteeItaly: Ministry of Health
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 75
Est. completion date September 2011
Est. primary completion date September 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Italy Gastroenterology Unit - University Hospital of Modena Modena

Sponsors (1)
Lead Sponsor Collaborator
Prof. Facchinetti Fabio

Country where clinical trial is conducted

Italy, 

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