Diagnosis of Spontaneous Bacterial Peritonitis (ARSDIASP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by Azienda Ospedaliera di Lecco
Sponsor:
Information provided by (Responsible Party):
Agostino Colli, Azienda Ospedaliera di Lecco
ClinicalTrials.gov Identifier:
NCT01598870
First received: May 11, 2012
Last updated: November 15, 2012
Last verified: November 2012
  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 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 ] [ Designated as safety issue: No ]

    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: August 2013
Estimated Primary Completion Date: July 2013 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: May 11, 2012
Last Updated: November 15, 2012
Health Authority: Italy: Ethics Committee

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

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

ClinicalTrials.gov processed this record on September 18, 2014