Procalcitonin in Cirrhotic Patients at High Risk for Sepsis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Prof. Facchinetti Fabio, University of Modena and Reggio Emilia
ClinicalTrials.gov Identifier:
NCT01578226
First received: April 13, 2012
Last updated: NA
Last verified: April 2012
History: No changes posted
  Purpose

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.


Condition
Cirrhosis
Ascites
Sepsis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Role of Procalcitonin (PCT) for the Diagnosis of Sepsis in Ascitic Cirrhotic Patients

Resource links provided by NLM:


Further study details as provided by University of Modena and Reggio Emilia:

Biospecimen Retention:   Samples Without DNA

Serum


Enrollment: 75
Study Start Date: October 2009
Study Completion Date: September 2011
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Decompensated cirrhotic patients
Cirrhotic patients presenting with clinically detectable ascites (Grade 2 o Grade 3)

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01578226

Locations
Italy
Gastroenterology Unit - University Hospital of Modena
Modena, Italy, 41124
Sponsors and Collaborators
Prof. Facchinetti Fabio
Investigators
Principal Investigator: Filippo Schepis, MD University of Modena and Reggio Emilia
  More Information

No publications provided

Responsible Party: Prof. Facchinetti Fabio, PRS Admin, University of Modena and Reggio Emilia
ClinicalTrials.gov Identifier: NCT01578226     History of Changes
Other Study ID Numbers: PCTCIRR
Study First Received: April 13, 2012
Last Updated: April 13, 2012
Health Authority: Italy: Ethics Committee
Italy: Ministry of Health

Keywords provided by University of Modena and Reggio Emilia:
Cirrhosis
Ascites
Decompensation
Bacterial infection
Sepsis
Procalcitonin
PCT

Additional relevant MeSH terms:
Ascites
Liver Cirrhosis
Fibrosis
Sepsis
Toxemia
Pathologic Processes
Liver Diseases
Digestive System Diseases
Infection
Systemic Inflammatory Response Syndrome
Inflammation

ClinicalTrials.gov processed this record on April 17, 2014