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

April 13, 2012
April 13, 2012
October 2009
September 2010   (final data collection date for primary outcome measure)
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No Changes Posted
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Procalcitonin in Cirrhotic Patients at High Risk for Sepsis
Role of Procalcitonin (PCT) for the Diagnosis of Sepsis in Ascitic Cirrhotic Patients

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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples Without DNA
Description:

Serum

Non-Probability Sample

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

  • Cirrhosis
  • Ascites
  • Sepsis
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Decompensated cirrhotic patients
Cirrhotic patients presenting with clinically detectable ascites (Grade 2 o Grade 3)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
75
September 2011
September 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01578226
PCTCIRR
No
Prof. Facchinetti Fabio, University of Modena and Reggio Emilia
Prof. Facchinetti Fabio
Not Provided
Principal Investigator: Filippo Schepis, MD University of Modena and Reggio Emilia
University of Modena and Reggio Emilia
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP