Clinical Trial: Diagnosis of Spontaneous Bacterial Peritonitis

Study Status: Terminated
Recruit Status: Unknown status
Study Type: Observational

Official Title: Redefinition of Diagnostic Criteria for Spontaneous Bacterial Peritonitis: Assessment of Accuracy of Available Tests and of Reference Standard

Brief Summary: The study is aimed to revise the current criteria for the diagnosis of spontaneous bacterial peritonitis and the decisional thresholds to start treatment. The accuracy of current diagnostic tests will be compared with that of new tests, which could potentially become more accurate reference standards. This could lead to the definition of a more accurate and effective diagnostic algorithm.

Detailed Summary:
Sponsor: Azienda Ospedaliera di Lecco

Current Primary Outcome: Comparing the accuracy of current reference standard for the diagnosis of spontaneous bacterial peritonitis, i.e. neutrophil count in ascitic fluid of >250/mm3 as determined by microscopy, with alternative diagnostic tests. [ Time Frame: One month ]

Reference standard is neutrophil count in ascitic fluid of >250/mm3 as determined by microscopy.

Alternative diagnostic tests are: Leukocyte count by automated counters; reagent strips for leukocyte esterase and for lactoferrin; ascitic fluid pH; leukocyte cytometry; bacterial DNA detection and quantification.

Discrepancies between reference standard and alternative tests will be assessed by one month clinical follow up.



Original Primary Outcome: Comparing the accuracy of current reference standard for the diagnosis of spontaneous bacterial peritonitis, i.e. neutrophil count in ascitic fluid of >250/mm3 as determined by microscopy, with alternative diagnostic tests. [ Time Frame: One month ]

Reference standard is neutrophil count in ascitic fluid of >250/mm3 as determined by microscopy.

Alternative diagnostic tests are: Leukocyte count by automated counters; reagent strips for leukocyte esterase and for lactoferrin; ascitic fluid pH; leukocyte cytometry; bacterial DNA detection and quantification.

Discrepancies between refernce standard and alternative tests will be assessed by one month clinical follow up.



Current Secondary Outcome:

Original Secondary Outcome:

Information By: Azienda Ospedaliera di Lecco

Dates:
Date Received: May 11, 2012
Date Started: May 2012
Date Completion: October 2015
Last Updated: January 13, 2015
Last Verified: January 2015