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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with cirrhosis and ascites | Patients requiring diagnostic and/or therapeutic paracentesis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diagnostic tests | Other | Leukocyte count by automated counters; reagent strips for leukocyte esterase and for lactoferrin; ascitic fluid pH; leukocyte cytometry; bacterial DNA detection and quantification. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | One month |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with cirrhosis and ascites requiring paracentesis.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Agostino Colli, MD | Contact | +390341489670 | a.colli@ospedale.lecco.it | |
| Pietro Pozzoni, MD | Contact | +390341489687 | p.pozzoni@ospedale.lecco.it |
| Name | Affiliation | Role |
|---|---|---|
| Agostino Colli, MD | AO Provincia di Lecco, Department of Medicine, A. Manzoni Hospital, Lecco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Medicine, A. Manzoni Hospital | Recruiting | Lecco | 23900 | Italy |
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Blood and ascitic fluid samples stored at -80°C