Diagnosis of Spontaneous Bacterial Peritonitis (ARSDIASP)
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Redefinition of Diagnostic Criteria for Spontaneous Bacterial Peritonitis: Assessment of Accuracy of Available Tests and of Reference Standard|
- 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 ] [ Designated as safety issue: No ]
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.
Biospecimen Retention: Samples With DNA
Blood and ascitic fluid samples stored at -80°C
|Study Start Date:||May 2012|
|Estimated Study Completion Date:||October 2015|
|Estimated Primary Completion Date:||July 2015 (Final data collection date for primary outcome measure)|
Patients with cirrhosis and ascites
Patients requiring diagnostic and/or therapeutic paracentesis.
Other: Diagnostic tests
Leukocyte count by automated counters; reagent strips for leukocyte esterase and for lactoferrin; ascitic fluid pH; leukocyte cytometry; bacterial DNA detection and quantification.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01598870
|Contact: Agostino Colli, MDfirstname.lastname@example.org|
|Contact: Pietro Pozzoni, MDemail@example.com|
|Department of Medicine, A. Manzoni Hospital||Recruiting|
|Lecco, Italy, 23900|
|Contact: Agostino Colli, MD +390341489670 firstname.lastname@example.org|
|Contact: Pietro Pozzoni, MD +390341489687 email@example.com|
|Principal Investigator: Agostino Colli, MD|
|Principal Investigator:||Agostino Colli, MD||AO Provincia di Lecco, Department of Medicine, A. Manzoni Hospital, Lecco|