Diagnosis of Spontaneous Bacterial Peritonitis (ARSDIASP)
|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
|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|