- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01598870
Diagnosis of Spontaneous Bacterial Peritonitis (ARSDIASP)
Redefinition of Diagnostic Criteria for Spontaneous Bacterial Peritonitis: Assessment of Accuracy of Available Tests and of Reference Standard
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Agostino Colli, MD
- Phone Number: +390341489670
- Email: a.colli@ospedale.lecco.it
Study Contact Backup
- Name: Pietro Pozzoni, MD
- Phone Number: +390341489687
- Email: p.pozzoni@ospedale.lecco.it
Study Locations
-
-
-
Lecco, Italy, 23900
- Recruiting
- Department of Medicine, A. Manzoni Hospital
-
Contact:
- Agostino Colli, MD
- Phone Number: +390341489670
- Email: a.colli@ospedale.lecco.it
-
Contact:
- Pietro Pozzoni, MD
- Phone Number: +390341489687
- Email: p.pozzoni@ospedale.lecco.it
-
Principal Investigator:
- Agostino Colli, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients with cirrhosis and ascites
Patients requiring diagnostic and/or therapeutic paracentesis.
|
Leukocyte count by automated counters; reagent strips for leukocyte esterase and for lactoferrin; ascitic fluid pH; leukocyte cytometry; bacterial DNA detection and quantification.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
One month
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Agostino Colli, MD, AO Provincia di Lecco, Department of Medicine, A. Manzoni Hospital, Lecco
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AOLecco001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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