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Taurolock for Preventing Bacterial Peritonitis During Renal Insufficiency

Primary Purpose

Peritonitis, Catheter-related Infections, Renal Insufficiency

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Taurolock
Placebo
Sponsored by
Centre Hospitalier Universitaire de Nīmes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Peritonitis focused on measuring Dialysis

Eligibility Criteria

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

Inclusion Criteria:

  • 18 years or older
  • Renal insufficiency, stage V (HAS 2007 classification)
  • Requires incident peritoneal dialysis
  • No signs of peritoneal infection on inclusion
  • signed consent
  • affiliated with a social security system

Exclusion Criteria:

  • Patient will have a renal transplant in the upcoming year following dialysis
  • Survival prognosis for one year is weak
  • allergy to citrate, (cyclo)-taurolidine, or heparin
  • patient is taking medication with a known contra-indication with citrate or (cyclo)-taurolidine
  • patient has a thrombopenia caused by heparin
  • impossible to inform the patient correctly
  • patient under guardianship
  • patient already included in another biomedical research protocol
  • no signed consent
  • no social security system

Sites / Locations

  • CHU de Nîmes - Hôpital Universitaire Carémeau
  • CH d'Avignon - Centre Hospitalier Henri Duffaut
  • CHU de Caen - Hôpital Clemenceau
  • CH de Chambéry
  • CH de Colmar - Hôpitaux Civils de Colmar
  • Association CALYDIAL Vienne
  • Centre Hospitalier Départemental Vendée - Site de la Roche sur Yon
  • AIDER - Clinque Jacques Mirouze
  • APHP - Groupe Hospitalier Pitié-Salpetrière
  • CH Pontoise - Centre Hospitalier René Dubos
  • Association AUB Santé Quimper
  • Centre Hospitalier Regional - Site Groupe Hospitalier Sud Réunion (GHSR)
  • CH de Valenciennes - Hôpital Jean Bernard et Hôtel Dieu
  • ALTIR - Hôpital Brabois
  • Association APURAD

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Taurolock

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Occurence of bacterial peritonitis

Secondary Outcome Measures

Full Information

First Posted
April 8, 2010
Last Updated
December 17, 2015
Sponsor
Centre Hospitalier Universitaire de Nīmes
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1. Study Identification

Unique Protocol Identification Number
NCT01101087
Brief Title
Taurolock for Preventing Bacterial Peritonitis During Renal Insufficiency
Official Title
Efficacity of Taurolock in Preventing Primary Bacterial Peritonitis in Patients Undergoing Peritoneal Dialysis for Renal Insufficiency: a Randomized, Multicenter, Double Blind Study With Placebo
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Dialysis catheters are sites of bacterial proliferation. The purpose of this study is to determine whether or not the use of Taurolock (a catheter lock solution) can prevent bacterial peritonitis in patients undergoing peritoneal dialysis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peritonitis, Catheter-related Infections, Renal Insufficiency
Keywords
Dialysis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Taurolock
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
Taurolock
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Injectable sodium chloride conditioned in exactly the same manner as the experimental product.
Primary Outcome Measure Information:
Title
Occurence of bacterial peritonitis
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years or older Renal insufficiency, stage V (HAS 2007 classification) Requires incident peritoneal dialysis No signs of peritoneal infection on inclusion signed consent affiliated with a social security system Exclusion Criteria: Patient will have a renal transplant in the upcoming year following dialysis Survival prognosis for one year is weak allergy to citrate, (cyclo)-taurolidine, or heparin patient is taking medication with a known contra-indication with citrate or (cyclo)-taurolidine patient has a thrombopenia caused by heparin impossible to inform the patient correctly patient under guardianship patient already included in another biomedical research protocol no signed consent no social security system
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernard Branger, MD
Organizational Affiliation
Centre Hospitalier Universitaire de Nîmes
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Nîmes - Hôpital Universitaire Carémeau
City
Nimes
State/Province
Gard
ZIP/Postal Code
30029
Country
France
Facility Name
CH d'Avignon - Centre Hospitalier Henri Duffaut
City
Avignon
ZIP/Postal Code
84902
Country
France
Facility Name
CHU de Caen - Hôpital Clemenceau
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
CH de Chambéry
City
Chambery
ZIP/Postal Code
73011
Country
France
Facility Name
CH de Colmar - Hôpitaux Civils de Colmar
City
Colmar
ZIP/Postal Code
68024
Country
France
Facility Name
Association CALYDIAL Vienne
City
Irigny
ZIP/Postal Code
69540
Country
France
Facility Name
Centre Hospitalier Départemental Vendée - Site de la Roche sur Yon
City
La Roche sur Yon
ZIP/Postal Code
85925
Country
France
Facility Name
AIDER - Clinque Jacques Mirouze
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
APHP - Groupe Hospitalier Pitié-Salpetrière
City
Paris
ZIP/Postal Code
75651
Country
France
Facility Name
CH Pontoise - Centre Hospitalier René Dubos
City
Pontoise
ZIP/Postal Code
95300
Country
France
Facility Name
Association AUB Santé Quimper
City
Quimper
ZIP/Postal Code
29000
Country
France
Facility Name
Centre Hospitalier Regional - Site Groupe Hospitalier Sud Réunion (GHSR)
City
Saint Pierre
ZIP/Postal Code
97448
Country
France
Facility Name
CH de Valenciennes - Hôpital Jean Bernard et Hôtel Dieu
City
Valenciennes
ZIP/Postal Code
59322
Country
France
Facility Name
ALTIR - Hôpital Brabois
City
Vandoeuvre les Nancy Cedex
ZIP/Postal Code
54504
Country
France
Facility Name
Association APURAD
City
Paéa
ZIP/Postal Code
98711
Country
French Polynesia

12. IPD Sharing Statement

Learn more about this trial

Taurolock for Preventing Bacterial Peritonitis During Renal Insufficiency

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