Diagnosis of Spontaneous Bacterial Peritonitis (ARSDIASP)
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|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|