Taurolock for Preventing Bacterial Peritonitis During Renal Insufficiency

Centre Hospitalier Universitaire de Nīmes150 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

150

Conditions

Peritonitis Catheter-related Infections Renal Insufficiency

Interventions

TaurolockDEVICE

PlaceboOTHER

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (15)

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, Gard, France

CH d'Avignon - Centre Hospitalier Henri Duffaut

Avignon, France

CHU de Caen - Hôpital Clemenceau

Outcomes

Primary Outcomes

Occurence of bacterial peritonitis

Time frame: 24 months

Data from ClinicalTrials.gov

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