Clinical trial NCT02085915: Evaluation of the Strip PeriScreen for the Fast Diagnosis of the Spontaneous Infection of the Liquid of Ascites During the Cirrhosis
Official title: Evaluation of the Strip PeriScreen for the Fast Diagnosis of the Spontaneous Infection of the Liquid of Ascites During the Cirrhosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cirrhosis
Liquid of Ascites
Infection
Lead sponsor: Centre Hospitalier Departemental Vendee
Sponsor class: OTHER
First posted: 2014-03-13
Enrollment: 670
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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.

Primary outcomes:
measure: liquid of ascites spontaneous infection
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Haine-Saint-Paul
country: Belgium
facility: Hopital Jolimont
city: Amiens
country: France
facility: CH Amiens
city: Besançon
country: France
facility: CHU Besançon
city: Brest
country: France
facility: CHRU de Brest
city: Caen
country: France
facility: CH Caen
city: Cholet
country: France
facility: CH Cholet
city: Clichy
country: France
facility: Hopîtal Beaujon
city: Creil
country: France
facility: Hopital Laennec
city: Dijon
country: France
facility: CH Dijon
city: Gonesse
country: France
facility: CH Gonesse
city: La Roche sur Yon
country: France
facility: CHD Vendée
city: Lille
country: France
facility: CH Lille
city: Nice
country: France
facility: CHU Nice
city: Orléans
country: France
facility: CH Orléans
city: Reims
country: France
facility: CH Reims
city: Rennes
country: France
facility: CH Rennes
city: Rouen
country: France
facility: CH Rouen
city: Saint Antoine
country: France
facility: CH St Antoine
city: Saint-Brieuc
country: France
facility: CH Yves Le Foll
city: Saint-Denis
country: France
facility: CH Saint-Denis - Hôpital de la Fontaine
city: Toulouse
country: France
facility: Hôpital Purpan
city: Vannes
country: France
facility: CH Vannes
Study officials:
affiliation: CHD Vendée La Roche sur Yon
name: Matthieu SCHNEE, Dr
role: STUDY_DIRECTOR
References: