Diagnosis of Spontaneous Bacterial Peritonitis (ARSDIASP)
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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 |
- 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 |
Patients with cirrhosis and ascites requiring paracentesis.
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| Contact: Agostino Colli, MD | +390341489670 | a.colli@ospedale.lecco.it |
| Contact: Pietro Pozzoni, MD | +390341489687 | p.pozzoni@ospedale.lecco.it |
| 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 | |
| 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 Peritoneal Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013