Clinical trial NCT01101087: 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
Overall status: COMPLETED
Phase: NA
Conditions: Peritonitis
Catheter-related Infections
Renal Insufficiency
Keywords: Dialysis
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2010-04-09
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Occurence of bacterial peritonitis
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nimes
country: France
facility: CHU de Nîmes - Hôpital Universitaire Carémeau
state: Gard
city: Avignon
country: France
facility: CH d'Avignon - Centre Hospitalier Henri Duffaut
city: Caen
country: France
facility: CHU de Caen - Hôpital Clemenceau
city: Chambery
country: France
facility: CH de Chambéry
city: Colmar
country: France
facility: CH de Colmar - Hôpitaux Civils de Colmar
city: Irigny
country: France
facility: Association CALYDIAL Vienne
city: La Roche sur Yon
country: France
facility: Centre Hospitalier Départemental Vendée - Site de la Roche sur Yon
city: Montpellier
country: France
facility: AIDER - Clinque Jacques Mirouze
city: Paris
country: France
facility: APHP - Groupe Hospitalier Pitié-Salpetrière
city: Pontoise
country: France
facility: CH Pontoise - Centre Hospitalier René Dubos
city: Quimper
country: France
facility: Association AUB Santé Quimper
city: Saint Pierre
country: France
facility: Centre Hospitalier Regional - Site Groupe Hospitalier Sud Réunion (GHSR)
city: Valenciennes
country: France
facility: CH de Valenciennes - Hôpital Jean Bernard et Hôtel Dieu
city: Vandoeuvre les Nancy Cedex
country: France
facility: ALTIR - Hôpital Brabois
city: Paéa
country: French Polynesia
facility: Association APURAD
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Bernard Branger, MD
role: PRINCIPAL_INVESTIGATOR
References: