We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Procalcitonin in Cirrhotic Patients at High Risk for Sepsis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01578226
Recruitment Status : Completed
First Posted : April 16, 2012
Last Update Posted : April 16, 2012
Information provided by (Responsible Party):

April 13, 2012
April 16, 2012
April 16, 2012
October 2009
September 2010   (Final data collection date for primary outcome measure)
Not Provided
Not Provided
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
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.
Not Provided
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Non-Probability Sample
All ascitic cirrhotic patients admitted to our third level Liver Unit.
  • Cirrhosis
  • Ascites
  • Sepsis
Not Provided
Decompensated cirrhotic patients
Cirrhotic patients presenting with clinically detectable ascites (Grade 2 o Grade 3)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
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