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Taurolock for Preventing Bacterial Peritonitis During Renal Insufficiency

Sponsor
Centre Hospitalier Universitaire de Nīmes (Other)
Overall Status
Completed
CT.gov ID
NCT01101087
Collaborator
(none)
150
Enrollment
15
Locations
2
Arms
65
Duration (Months)
10
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Taurolock
  • Other: Placebo
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Prevention
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 Start Date :
Jul 1, 2010
Actual Primary Completion Date :
Dec 1, 2015
Actual Study Completion Date :
Dec 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: Taurolock

Device: Taurolock
Placebo Comparator: Placebo

Other: Placebo
Injectable sodium chloride conditioned in exactly the same manner as the experimental product.

Outcome Measures

Primary Outcome Measures

  1. Occurence of bacterial peritonitis [24 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU de Nîmes - Hôpital Universitaire Carémeau Nimes Gard France 30029
2 CH d'Avignon - Centre Hospitalier Henri Duffaut Avignon France 84902
3 CHU de Caen - Hôpital Clemenceau Caen France 14033
4 CH de Chambéry Chambery France 73011
5 CH de Colmar - Hôpitaux Civils de Colmar Colmar France 68024
6 Association CALYDIAL Vienne Irigny France 69540
7 Centre Hospitalier Départemental Vendée - Site de la Roche sur Yon La Roche sur Yon France 85925
8 AIDER - Clinque Jacques Mirouze Montpellier France 34295
9 APHP - Groupe Hospitalier Pitié-Salpetrière Paris France 75651
10 CH Pontoise - Centre Hospitalier René Dubos Pontoise France 95300
11 Association AUB Santé Quimper Quimper France 29000
12 Centre Hospitalier Regional - Site Groupe Hospitalier Sud Réunion (GHSR) Saint Pierre France 97448
13 CH de Valenciennes - Hôpital Jean Bernard et Hôtel Dieu Valenciennes France 59322
14 ALTIR - Hôpital Brabois Vandoeuvre les Nancy Cedex France 54504
15 Association APURAD Paéa French Polynesia 98711

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de Nīmes

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01101087
Other Study ID Numbers:
  • PHRC-N/2009/BB
  • 2009-A00599-48
First Posted:
Apr 9, 2010
Last Update Posted:
Dec 18, 2015
Last Verified:
Dec 1, 2015
Keywords provided by Centre Hospitalier Universitaire de Nīmes
Dialysis
Additional relevant MeSH terms:
Peritonitis
Catheter-Related Infections
Renal Insufficiency

Study Results

No Results Posted as of Dec 18, 2015