Evaluation of the Strip PeriScreen for the Fast Diagnosis of the Spontaneous Infection of the Liquid of Ascites During the Cirrhosis

Not Applicable

Completed

• Conditions: Liquid of Ascites; Infection; Cirrhosis
• Interventions: Other: strip Peri Screen

• Registration Number: NCT02085915
• Lead Sponsor: Centre Hospitalier Departemental Vendee

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-03-07
• Study First Submitted QC: 2014-03-11
• Study First Posted: 2014-03-13
• Primary Completion: 2015-08
• Status Verified: 2015-09
• Study Completion: 2015-09
• Last Update Submitted: 2015-09-15
• Last Update Posted: 2015-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 670

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
strip Peri Screen	strip Peri Screen	-

Primary Outcome Measures

Name	Time	Method
liquid of ascites spontaneous infection	Baseline	Periscreen strip compared to the cytological analysis

Trial Locations

Locations (22)

CHU Besançon; 🇫🇷 Besançon, France

CHRU de Brest; 🇫🇷 Brest, France

CH Caen; 🇫🇷 Caen, France

CH Amiens; 🇫🇷 Amiens, France

Hopital Laennec; 🇫🇷 Creil, France

CH Gonesse; 🇫🇷 Gonesse, France

CHU Nice; 🇫🇷 Nice, France

CH Yves Le Foll; 🇫🇷 Saint-Brieuc, France

Hopital Jolimont; 🇧🇪 Haine-Saint-Paul, Belgium

CH Reims; 🇫🇷 Reims, France

CH Rennes; 🇫🇷 Rennes, France

CH Dijon; 🇫🇷 Dijon, France

CH St Antoine; 🇫🇷 Saint Antoine, France

CH Saint-Denis - Hôpital de la Fontaine; 🇫🇷 Saint-Denis, France

CH Vannes; 🇫🇷 Vannes, France

Hôpital Purpan; 🇫🇷 Toulouse, France

CH Cholet; 🇫🇷 Cholet, France

Hopîtal Beaujon; 🇫🇷 Clichy, France

CHD Vendée; 🇫🇷 La Roche sur Yon, France

CH Lille; 🇫🇷 Lille, France

CH Orléans; 🇫🇷 Orléans, France

CH Rouen; 🇫🇷 Rouen, France