MedTrace Logo

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

NCT02798939 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 123

Last updated 2020-07-17

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

  • Centre Hospitalier Universitaire, Amiens

    lead OTHER

Principal Investigators

  • Eric NGUYEN KHAC, MD, PhD · CHU Amiens

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-01
Primary Completion
2017-02-14
Completion
2017-02-14

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02798939 on ClinicalTrials.gov