Diagnosis of Spontaneous Bacterial Peritonitis
ARSDIASP
Redefinition of Diagnostic Criteria for Spontaneous Bacterial Peritonitis: Assessment of Accuracy of Available Tests and of Reference Standard
1 other identifier
observational
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2012
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 11, 2012
CompletedFirst Posted
Study publicly available on registry
May 15, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedJanuary 14, 2015
January 1, 2015
3.2 years
May 11, 2012
January 13, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
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
Study Arms (1)
Patients with cirrhosis and ascites
Patients requiring diagnostic and/or therapeutic paracentesis.
Interventions
Leukocyte count by automated counters; reagent strips for leukocyte esterase and for lactoferrin; ascitic fluid pH; leukocyte cytometry; bacterial DNA detection and quantification.
Eligibility Criteria
Patients with cirrhosis and ascites requiring paracentesis.
You may qualify if:
- Patients with cirrhosis and ascites with clinical indication to carry out a diagnostic and/or therapeutic paracentesis.
You may not qualify if:
- Etiology of ascites other than cirrhosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Medicine, A. Manzoni Hospital
Lecco, 23900, Italy
Biospecimen
Blood and ascitic fluid samples stored at -80°C
Study Officials
- PRINCIPAL INVESTIGATOR
Agostino Colli, MD
AO Provincia di Lecco, Department of Medicine, A. Manzoni Hospital, Lecco
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, Head of Internal Medicine Department AO Provincia di Lecco
Study Record Dates
First Submitted
May 11, 2012
First Posted
May 15, 2012
Study Start
May 1, 2012
Primary Completion
July 1, 2015
Study Completion
October 1, 2015
Last Updated
January 14, 2015
Record last verified: 2015-01