Taurolock for Preventing Bacterial Peritonitis During Renal Insufficiency

December 17, 2015 updated by: Centre Hospitalier Universitaire de Nīmes

Efficacity of Taurolock in Preventing Primary Bacterial Peritonitis in Patients Undergoing Peritoneal Dialysis for Renal Insufficiency: a Randomized, Multicenter, Double Blind Study With Placebo

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Avignon, France, 84902
        • CH d'Avignon - Centre Hospitalier Henri Duffaut
      • Caen, France, 14033
        • CHU de Caen - Hôpital Clemenceau
      • Chambery, France, 73011
        • Ch De Chambery
      • Colmar, France, 68024
        • CH de Colmar - Hôpitaux Civils de Colmar
      • Irigny, France, 69540
        • Association CALYDIAL Vienne
      • La Roche sur Yon, France, 85925
        • Centre Hospitalier Départemental Vendée - Site de la Roche sur Yon
      • Montpellier, France, 34295
        • AIDER - Clinque Jacques Mirouze
      • Paris, France, 75651
        • APHP - Groupe Hospitalier Pitié-Salpetrière
      • Pontoise, France, 95300
        • CH Pontoise - Centre Hospitalier René Dubos
      • Quimper, France, 29000
        • Association AUB Santé Quimper
      • Saint Pierre, France, 97448
        • Centre Hospitalier Regional - Site Groupe Hospitalier Sud Réunion (GHSR)
      • Valenciennes, France, 59322
        • CH de Valenciennes - Hôpital Jean Bernard et Hôtel Dieu
      • Vandoeuvre les Nancy Cedex, France, 54504
        • ALTIR - Hôpital Brabois
    • Gard
      • Nimes, Gard, France, 30029
        • CHU de Nimes - Hopital Universitaire Caremeau
  • French Polynesia
      • Paéa, French Polynesia, 98711
        • Association APURAD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Other: Placebo
Injectable sodium chloride conditioned in exactly the same manner as the experimental product.
Experimental: Taurolock
Device: Taurolock

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Occurence of bacterial peritonitis
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nīmes

Investigators

  • Principal Investigator: Bernard Branger, MD, Centre Hospitalier Universitaire de Nīmes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

April 8, 2010

First Submitted That Met QC Criteria

April 8, 2010

First Posted (Estimate)

April 9, 2010

Study Record Updates

Last Update Posted (Estimate)

December 18, 2015

Last Update Submitted That Met QC Criteria

December 17, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHRC-N/2009/BB
  • 2009-A00599-48 (Other Identifier: RCB number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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