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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Sepsis
Toxemia
Infection
Inflammation
Pathologic Processes
Systemic Inflammatory Response Syndrome

ClinicalTrials.gov processed this record on October 23, 2014