Taurolock for Preventing Bacterial Peritonitis During Renal Insufficiency

Not Applicable

Completed

• Conditions: Peritonitis; Catheter-related Infections; Renal Insufficiency
• Interventions: Device: Taurolock; Other: Placebo

• Registration Number: NCT01101087
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-04-08
• Study First Submitted QC: 2010-04-08
• Study First Posted: 2010-04-09
• Study Start: 2010-07
• Status Verified: 2015-12
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Last Update Submitted: 2015-12-17
• Last Update Posted: 2015-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Taurolock	Taurolock	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Occurence of bacterial peritonitis	24 months

Trial Locations

Locations (15)

CHU de Nîmes - Hôpital Universitaire Carémeau; 🇫🇷 Nimes, Gard, France

Association APURAD; 🇵🇫 Paéa, French Polynesia

CH d'Avignon - Centre Hospitalier Henri Duffaut; 🇫🇷 Avignon, France

Centre Hospitalier Départemental Vendée - Site de la Roche sur Yon; 🇫🇷 La Roche sur Yon, France

CHU de Caen - Hôpital Clemenceau; 🇫🇷 Caen, France

CH de Chambéry; 🇫🇷 Chambery, France

Association CALYDIAL Vienne; 🇫🇷 Irigny, France

Association AUB Santé Quimper; 🇫🇷 Quimper, France

APHP - Groupe Hospitalier Pitié-Salpetrière; 🇫🇷 Paris, France

AIDER - Clinque Jacques Mirouze; 🇫🇷 Montpellier, France

CH Pontoise - Centre Hospitalier René Dubos; 🇫🇷 Pontoise, France

Centre Hospitalier Regional - Site Groupe Hospitalier Sud Réunion (GHSR); 🇫🇷 Saint Pierre, France

CH de Valenciennes - Hôpital Jean Bernard et Hôtel Dieu; 🇫🇷 Valenciennes, France

ALTIR - Hôpital Brabois; 🇫🇷 Vandoeuvre les Nancy Cedex, France

CH de Colmar - Hôpitaux Civils de Colmar; 🇫🇷 Colmar, France