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Diagnosis of Spontaneous Bacterial Peritonitis (ARSDIASP)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2015 by Agostino Colli, Azienda Ospedaliera di Lecco.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01598870
First Posted: May 15, 2012
Last Update Posted: January 14, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Agostino Colli, Azienda Ospedaliera di Lecco
  Purpose
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.

Condition Intervention
Spontaneous Bacterial Peritonitis Other: Diagnostic tests

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Redefinition of Diagnostic Criteria for Spontaneous Bacterial Peritonitis: Assessment of Accuracy of Available Tests and of Reference Standard

Further study details as provided by Agostino Colli, Azienda Ospedaliera di Lecco:

Primary Outcome Measures:
  • 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
Blood and ascitic fluid samples stored at -80°C

Estimated Enrollment: 100
Study Start Date: May 2012
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with cirrhosis and ascites requiring paracentesis.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

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


Contacts
Contact: Agostino Colli, MD +390341489670 a.colli@ospedale.lecco.it
Contact: Pietro Pozzoni, MD +390341489687 p.pozzoni@ospedale.lecco.it

Locations
Italy
Department of Medicine, A. Manzoni Hospital Recruiting
Lecco, Italy, 23900
Contact: Agostino Colli, MD    +390341489670    a.colli@ospedale.lecco.it   
Contact: Pietro Pozzoni, MD    +390341489687    p.pozzoni@ospedale.lecco.it   
Principal Investigator: Agostino Colli, MD         
Sponsors and Collaborators
Azienda Ospedaliera di Lecco
Investigators
Principal Investigator: Agostino Colli, MD AO Provincia di Lecco, Department of Medicine, A. Manzoni Hospital, Lecco
  More Information

Responsible Party: Agostino Colli, MD, Head of Internal Medicine Department AO Provincia di Lecco, Azienda Ospedaliera di Lecco
ClinicalTrials.gov Identifier: NCT01598870     History of Changes
Other Study ID Numbers: AOLecco001
First Submitted: May 11, 2012
First Posted: May 15, 2012
Last Update Posted: January 14, 2015
Last Verified: January 2015

Keywords provided by Agostino Colli, Azienda Ospedaliera di Lecco:
Spontaneous bacterial peritonitis.

Additional relevant MeSH terms:
Peritonitis
Intraabdominal Infections
Infection
Peritoneal Diseases
Digestive System Diseases