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Diagnosis of Spontaneous Bacterial Peritonitis

Redefinition of Diagnostic Criteria for Spontaneous Bacterial Peritonitis: Assessment of Accuracy of Available Tests and of Reference Standard

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01598870
Acronym
ARSDIASP
Enrollment
100
Registered
2012-05-15
Start date
2012-05-31
Completion date
2015-10-31
Last updated
2015-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spontaneous Bacterial Peritonitis

Keywords

Spontaneous bacterial peritonitis.

Brief summary

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.

Interventions

Leukocyte count by automated counters; reagent strips for leukocyte esterase and for lactoferrin; ascitic fluid pH; leukocyte cytometry; bacterial DNA detection and quantification.

Sponsors

Azienda Ospedaliera di Lecco
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients with cirrhosis and ascites with clinical indication to carry out a diagnostic and/or therapeutic paracentesis.

Exclusion criteria

* Etiology of ascites other than cirrhosis

Design outcomes

Primary

MeasureTime frameDescription
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.One monthReference 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.

Countries

Italy

Contacts

Primary ContactAgostino Colli, MD
a.colli@ospedale.lecco.it+390341489670
Backup ContactPietro Pozzoni, MD
p.pozzoni@ospedale.lecco.it+390341489687

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026