N/A
N=649
Evaluation of the Strip PeriScreen for the Fast Diagnosis of the Spontaneous Infection of the Liquid of Ascites During the Cirrhosis
Cirrhosis · Liquid of Ascites · Infection
Bottom Line
View on ClinicalTrials.gov: NCT02085915 ↗Enrolled (actual)
649
Serious AEs
0.0%
Results posted
May 2026
Primary outcome: Primary: Sensitivity and Specificity — 91.7; 57.1; 12.0; 99.1 percentage
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- strip Peri Screen (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Centre Hospitalier Departemental Vendee
- Primary completion
- Aug 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sensitivity and Specificity |
91.7; 57.1; 12.0; 99.1 | — |
Summary
The forecast of the spontaneous infection of the liquid of ascites (ISLA) at the cirrhotic patient is still burdened by a heavy mortality. The fast diagnosis of the ISLA is thus an essential stake to improve the forecast.
Investigators would so like to estimate the interest of the strip PeriScreen for the fast diagnosis of the ISLA at cirrhotic patients . Investigators plan to include 670 patients, what would allow to make out a will at least on ascites 2000 on about twenty centers for duration estimated of 12 months.
Eligibility Criteria
Inclusion Criteria
- Male or female over 18 years
- Presence of ascites due to cirrhosis
- Hospitalization for a complication of cirrhosis (ascites first decompensation, gastrointestinal bleeding, encephalopathy, etc ...).
or
- Hospitalization to perform a paracentesis evacuated outpatient
- Patients on long-term antibiotic primary or secondary prophylaxis the spontaneous bacterial peritonitis and with clinical and/or biological signs that suggest spontaneous infection of ascite.
Exclusion Criteria
- Patients with ascites urgently admitted to hospital for suspected infection receiving antibiotics for more than 12 hours.
- chylous ascites,
- Hemorrhagic Ascites
- Biliary Ascites (straw)
- Ascites heterogeneous appearance
- Ascites not related to portal hypertension (peritoneal carcinomatosis, pancreatic ascites, tuberculosis, etc ...)
- Patient receiving imipenem IV.
- Patients on long-term antibiotic primary or secondary prophylaxis the spontaneous bacterial peritonitis without clinical and/or biological signs that suggest spontaneous infection of ascite.
Data sourced from ClinicalTrials.gov (NCT02085915). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.