- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02798939
Evaluation of Lactoferrin, Procalcitonin and Aution® Urine Dipsticks for the Diagnosis of Spontaneous Bacterial Peritonitis in Cirrhotic Patients
July 15, 2020 updated by: Centre Hospitalier Universitaire, Amiens
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.
Study Overview
Status
Terminated
Conditions
Study Type
Observational
Enrollment (Actual)
123
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Amiens, France, 80054
- CHU Amiens
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 99 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Cirrhotic patients requiring ascitic fluid aspiration, routine clinical practice
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
---|
cirrhotic patients
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
diagnostic performances of lactoferrin
Time Frame: D0
|
D0
|
diagnostic performances of PCT
Time Frame: D0
|
D0
|
diagnostic performances of Aution® urine dipstick
Time Frame: D0
|
D0
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Eric NGUYEN KHAC, MD, PhD, CHU Amiens
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2010
Primary Completion (Actual)
February 14, 2017
Study Completion (Actual)
February 14, 2017
Study Registration Dates
First Submitted
June 9, 2016
First Submitted That Met QC Criteria
June 9, 2016
First Posted (Estimate)
June 14, 2016
Study Record Updates
Last Update Posted (Actual)
July 17, 2020
Last Update Submitted That Met QC Criteria
July 15, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AOL09-NGUYEN-KHAC
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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