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

Terminated

• Conditions: Liver Cirrhosis

• Registration Number: NCT02798939
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-01
• Study First Submitted: 2016-06-09
• Study First Submitted QC: 2016-06-09
• Study First Posted: 2016-06-14
• Primary Completion: 2017-02-14
• Study Completion: 2017-02-14
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-15
• Last Update Posted: 2020-07-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 123

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
diagnostic performances of PCT	D0
diagnostic performances of lactoferrin	D0
diagnostic performances of Aution® urine dipstick	D0

Trial Locations

Locations (1)

CHU Amiens; 🇫🇷 Amiens, France