Diagnosis of Spontaneous Bacterial Peritonitis (ARSDIASP)
|ClinicalTrials.gov Identifier: NCT01598870|
Recruitment Status : Unknown
Verified January 2015 by Agostino Colli, Azienda Ospedaliera di Lecco.
Recruitment status was: Recruiting
First Posted : May 15, 2012
Last Update Posted : January 14, 2015
|Condition or disease||Intervention/treatment|
|Spontaneous Bacterial Peritonitis||Other: Diagnostic tests|
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Redefinition of Diagnostic Criteria for Spontaneous Bacterial Peritonitis: Assessment of Accuracy of Available Tests and of Reference Standard|
|Study Start Date :||May 2012|
|Estimated Primary Completion Date :||July 2015|
|Estimated Study Completion Date :||October 2015|
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.
- 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.
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01598870
|Contact: Agostino Colli, MDemail@example.com|
|Contact: Pietro Pozzoni, MDfirstname.lastname@example.org|
|Department of Medicine, A. Manzoni Hospital||Recruiting|
|Lecco, Italy, 23900|
|Contact: Agostino Colli, MD +390341489670 email@example.com|
|Contact: Pietro Pozzoni, MD +390341489687 firstname.lastname@example.org|
|Principal Investigator: Agostino Colli, MD|
|Principal Investigator:||Agostino Colli, MD||AO Provincia di Lecco, Department of Medicine, A. Manzoni Hospital, Lecco|