Diagnosis of Spontaneous Bacterial Peritonitis

• Conditions: Spontaneous Bacterial Peritonitis
• Interventions: Other: Diagnostic tests

• Registration Number: NCT01598870
• Lead Sponsor: Azienda Ospedaliera di Lecco

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-05-11
• Study First Submitted QC: 2012-05-11
• Study First Posted: 2012-05-15
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-13
• Last Update Posted: 2015-01-14
• Primary Completion: 2015-07
• Study Completion: 2015-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with cirrhosis and ascites	Diagnostic tests	Patients requiring diagnostic and/or therapeutic paracentesis.

Primary Outcome Measures

Name	Time	Method
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 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.

Trial Locations

Locations (1)

Department of Medicine, A. Manzoni Hospital; 🇮🇹 Lecco, Italy