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

NCT ID: NCT02085915

Last Updated: 2015-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

670 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2015-09-30

Brief Summary

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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

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Conditions

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Cirrhosis Liquid of Ascites Infection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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strip Peri Screen

Group Type OTHER

strip Peri Screen

Intervention Type OTHER

Interventions

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strip Peri Screen

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Departemental Vendee

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matthieu SCHNEE, Dr

Role: STUDY_DIRECTOR

CHD Vendée La Roche sur Yon

Locations

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Hopital Jolimont

Haine-Saint-Paul, , Belgium

Site Status

CH Amiens

Amiens, , France

Site Status

CHU Besançon

Besançon, , France

Site Status

CHRU de Brest

Brest, , France

Site Status

CH Caen

Caen, , France

Site Status

CH Cholet

Cholet, , France

Site Status

Hopîtal Beaujon

Clichy, , France

Site Status

Hopital Laennec

Creil, , France

Site Status

CH Dijon

Dijon, , France

Site Status

CH Gonesse

Gonesse, , France

Site Status

CHD Vendée

La Roche-sur-Yon, , France

Site Status

CH Lille

Lille, , France

Site Status

CHU Nice

Nice, , France

Site Status

CH Orléans

Orléans, , France

Site Status

CH Reims

Reims, , France

Site Status

CH Rennes

Rennes, , France

Site Status

CH Rouen

Rouen, , France

Site Status

CH St Antoine

Saint-Antoine, , France

Site Status

CH Yves Le Foll

Saint-Brieuc, , France

Site Status

CH Saint-Denis - Hôpital de la Fontaine

Saint-Denis, , France

Site Status

Hôpital Purpan

Toulouse, , France

Site Status

CH Vannes

Vannes, , France

Site Status

Countries

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Belgium France

Other Identifiers

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CHD 065-13

Identifier Type: -

Identifier Source: org_study_id

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