Diagnosis of Spontaneous Bacterial Peritonitis

NCT ID: NCT01598870

Last Updated: 2015-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-05-31

Study Completion Date

2015-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Spontaneous Bacterial Peritonitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with cirrhosis and ascites

Patients requiring diagnostic and/or therapeutic paracentesis.

Diagnostic tests

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda Ospedaliera di Lecco

OTHER

Sponsor Role lead

Responsible Party

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Agostino Colli

MD, Head of Internal Medicine Department AO Provincia di Lecco

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Agostino Colli, MD

Role: PRINCIPAL_INVESTIGATOR

AO Provincia di Lecco, Department of Medicine, A. Manzoni Hospital, Lecco

Locations

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Department of Medicine, A. Manzoni Hospital

Lecco, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Agostino Colli, MD

Role: CONTACT

+390341489670

Pietro Pozzoni, MD

Role: CONTACT

+390341489687

Facility Contacts

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Agostino Colli, MD

Role: primary

+390341489670

Pietro Pozzoni, MD

Role: backup

+390341489687

Other Identifiers

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AOLecco001

Identifier Type: -

Identifier Source: org_study_id

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