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Procalcitonin in Cirrhotic Patients at High Risk for Sepsis

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ClinicalTrials.gov Identifier: NCT01578226
Recruitment Status : Completed
First Posted : April 16, 2012
Last Update Posted : April 16, 2012
Sponsor:
Information provided by (Responsible Party):
Prof. Facchinetti Fabio, University of Modena and Reggio Emilia

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.

Condition or disease
Cirrhosis Ascites Sepsis

Study Type : Observational
Actual Enrollment : 75 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Role of Procalcitonin (PCT) for the Diagnosis of Sepsis in Ascitic Cirrhotic Patients
Study Start Date : October 2009
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis
U.S. FDA Resources

Group/Cohort
Decompensated cirrhotic patients
Cirrhotic patients presenting with clinically detectable ascites (Grade 2 o Grade 3)



Biospecimen Retention:   Samples Without DNA
Serum


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: April 16, 2012    Key Record Dates
Last Update Posted: April 16, 2012
Last Verified: April 2012

Keywords provided by Prof. Facchinetti Fabio, University of Modena and Reggio Emilia:
Cirrhosis
Ascites
Decompensation
Bacterial infection
Sepsis
Procalcitonin
PCT

Additional relevant MeSH terms:
Sepsis
Toxemia
Fibrosis
Ascites
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Calcitonin
Bone Density Conservation Agents
Physiological Effects of Drugs