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TerminatedNCT02798939Updated Jul 17, 2020

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

An observational study in Liver Cirrhosis, sponsored by Centre Hospitalier Universitaire, Amiens. Terminated at 1 site in France. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2020-07-17.

Sponsored by Centre Hospitalier Universitaire, Amiens · Observational

Why this study was terminated
investigator choice
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
123
Ages
18 Years to 99 Years
Sex
All
01

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.

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Conditions studied

  • Liver Cirrhosis

Keywords

  • spontaneous bacterial peritonitis
  • lactoferrin
  • procalcitonin
  • Aution® urine dipsticks
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In context

Peritonitis

185 studies on the registry are indexed under Peritonitis; 25 are open to participants now.

This study's enrollment of 123 is close to the median of 127 across 59 observational studies indexed under Peritonitis.

Browse Peritonitis studies →

Lead sponsor

Centre Hospitalier Universitaire, Amiens is the lead sponsor of 576 studies on the registry; 178 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Cirrhotic patients requiring ascitic fluid aspiration, routine clinical practice

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

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
123 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • cirrhotic patients
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What researchers measure

Primary outcomes

  1. diagnostic performances of lactoferrin

    Time frame: D0

  2. diagnostic performances of PCT

    Time frame: D0

  3. diagnostic performances of Aution® urine dipstick

    Time frame: D0

07

Study locations

1 site
  • CHU Amiens
    Amiens, 80054, France
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 17, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02798939
Lead sponsor
Centre Hospitalier Universitaire, Amiens
Responsible party
Sponsor
First posted
Jun 14, 2016
Start date
Mar 1, 2010
Primary completion
Feb 14, 2017
Completion
Feb 14, 2017
Last update
Jul 17, 2020

Study contacts

Eric NGUYEN KHAC, MD, PhD
principal investigator · CHU Amiens
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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