Evaluation of Lactoferrin, Procalcitonin and Aution® Urine Dipsticks for the Diagnosis of Spontaneous Bacterial Peritonitis in Cirrhotic Patients

Study Overview
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Brief Summary
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Bacterial infections are a major cause of mortality in cirrhotic patients in the context of gastrointestinal bleeding or spontaneous bacterial peritonitis (SBP). Rapid diagnosis of SBP is therefore an important research goal because the gold standard neutrophil count in ascitic fluid cannot be performed 24 hours a day in all healthcare structures. The use of urine dipsticks in ascites cannot be recommended at the present time due to their insufficient sensitivity with an unacceptable risk of false-negatives in the context of a fatal disease for which effective antibiotic therapy is available. Ascitic fluid lactoferrin assay has recently been demonstrated to be a very good diagnostic test for SBP. The investigators plan to conduct a prospective study on lactoferrin as well as procalcitonin (PCT) to determine the best laboratory test(s) for the rapid, automated diagnosis of SBP. These tests will be compared with the Aution® urine dipstick, which has been shown to present better diagnostic sensitivity than the Multistix® dipstick . This single-centre study (Amiens University Hospital) will be performed in the context of routine clinical practice on ascitic fluid that is usually incinerated.

Official Title
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Evaluation of Lactoferrin, Procalcitonin and Aution® Urine Dipsticks for the Diagnosis of Spontaneous Bacterial Peritonitis in Cirrhotic Patients

Conditions
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Liver Cirrhosis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients over 18 years, not unable major Cirrhosis diagnosed by liver histology (or a non-invasive test , biological, or Fibrotest Fibrometer , or physical Fibroscan® ) , or a set of clinical, laboratory , ultrasound and endoscopy . Presence of ascites puncture in the clinical part of routine care Exclusion Criteria: Ascites noncirrhotic origins : heart , nephrotic syndrome, peritoneal dialysis, tuberculosis, cancer peritoneal carcinomatosis , acute and chronic pancreatitis surgical peritonitis by perforation of hollow organ Haemoperitoneum pure or associated with ascites.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| cirrhotic patients<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diagnostic performances of lactoferrin |  | D0 | 
| diagnostic performances of PCT |  | D0 | 
| diagnostic performances of Aution® urine dipstick |  | D0 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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spontaneous bacterial peritonitis, lactoferrin, procalcitonin, Aution® urine dipsticks