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Evaluation of the Strip PeriScreen for the Fast Diagnosis of the Spontaneous Infection of the Liquid of Ascites During the Cirrhosis (Per-DRISLA)

Primary Purpose

Cirrhosis, Liquid of Ascites, Infection

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
strip Peri Screen
Sponsored by
Centre Hospitalier Departemental Vendee
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cirrhosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hopital Jolimont
  • CH Amiens
  • CHU Besançon
  • CHRU de Brest
  • CH Caen
  • CH Cholet
  • Hopîtal Beaujon
  • Hopital Laennec
  • CH Dijon
  • CH Gonesse
  • CHD Vendée
  • CH Lille
  • CHU Nice
  • CH Orléans
  • CH Reims
  • CH Rennes
  • CH Rouen
  • CH St Antoine
  • CH Yves Le Foll
  • CH Saint-Denis - Hôpital de la Fontaine
  • Hôpital Purpan
  • CH Vannes

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

strip Peri Screen

Arm Description

Outcomes

Primary Outcome Measures

liquid of ascites spontaneous infection
Periscreen strip compared to the cytological analysis

Secondary Outcome Measures

Full Information

First Posted
March 7, 2014
Last Updated
September 15, 2015
Sponsor
Centre Hospitalier Departemental Vendee
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1. Study Identification

Unique Protocol Identification Number
NCT02085915
Brief Title
Evaluation of the Strip PeriScreen for the Fast Diagnosis of the Spontaneous Infection of the Liquid of Ascites During the Cirrhosis
Acronym
Per-DRISLA
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

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Departemental Vendee

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis, Liquid of Ascites, Infection

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
670 (Actual)

8. Arms, Groups, and Interventions

Arm Title
strip Peri Screen
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
strip Peri Screen
Primary Outcome Measure Information:
Title
liquid of ascites spontaneous infection
Description
Periscreen strip compared to the cytological analysis
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthieu SCHNEE, Dr
Organizational Affiliation
CHD Vendée La Roche sur Yon
Official's Role
Study Director
Facility Information:
Facility Name
Hopital Jolimont
City
Haine-Saint-Paul
ZIP/Postal Code
B-7100
Country
Belgium
Facility Name
CH Amiens
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
CHU Besançon
City
Besançon
ZIP/Postal Code
25000
Country
France
Facility Name
CHRU de Brest
City
Brest
ZIP/Postal Code
29200
Country
France
Facility Name
CH Caen
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
CH Cholet
City
Cholet
ZIP/Postal Code
49300
Country
France
Facility Name
Hopîtal Beaujon
City
Clichy
ZIP/Postal Code
92118
Country
France
Facility Name
Hopital Laennec
City
Creil
ZIP/Postal Code
60109
Country
France
Facility Name
CH Dijon
City
Dijon
ZIP/Postal Code
21034
Country
France
Facility Name
CH Gonesse
City
Gonesse
ZIP/Postal Code
95300
Country
France
Facility Name
CHD Vendée
City
La Roche sur Yon
ZIP/Postal Code
85925
Country
France
Facility Name
CH Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
CHU Nice
City
Nice
ZIP/Postal Code
06200
Country
France
Facility Name
CH Orléans
City
Orléans
ZIP/Postal Code
45067
Country
France
Facility Name
CH Reims
City
Reims
ZIP/Postal Code
51092
Country
France
Facility Name
CH Rennes
City
Rennes
ZIP/Postal Code
35000
Country
France
Facility Name
CH Rouen
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
CH St Antoine
City
Saint Antoine
ZIP/Postal Code
75571
Country
France
Facility Name
CH Yves Le Foll
City
Saint-Brieuc
ZIP/Postal Code
22027
Country
France
Facility Name
CH Saint-Denis - Hôpital de la Fontaine
City
Saint-Denis
ZIP/Postal Code
93205
Country
France
Facility Name
Hôpital Purpan
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
CH Vannes
City
Vannes
ZIP/Postal Code
56017
Country
France

12. IPD Sharing Statement

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

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