Taurolock for Preventing Bacterial Peritonitis During Renal Insufficiency

Renal Insufficiency Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01101087
• Other study ID #: PHRC-N/2009/BB
• Secondary ID: 2009-A00599-48
• Status: Completed
• Phase: N/A
• First received: April 8, 2010
• Last updated: December 17, 2015
• Start date: July 2010
• Est. completion date: December 2015

Study information

• Verified date: December 2015
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Institutional Ethical CommitteeFrance: The Commission nationale de l’informatique et des libertés
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Catheter-related Infections
• Peritonitis
• Renal Insufficiency

Intervention

Device:
• Taurolock

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

Locations

Country	Name	City	State
France	CH d'Avignon - Centre Hospitalier Henri Duffaut	Avignon
France	CHU de Caen - Hôpital Clemenceau	Caen
France	CH de Chambéry	Chambery
France	CH de Colmar - Hôpitaux Civils de Colmar	Colmar
France	Association CALYDIAL Vienne	Irigny
France	Centre Hospitalier Départemental Vendée - Site de la Roche sur Yon	La Roche sur Yon
France	AIDER - Clinque Jacques Mirouze	Montpellier
France	CHU de Nîmes - Hôpital Universitaire Carémeau	Nimes	Gard
France	APHP - Groupe Hospitalier Pitié-Salpetrière	Paris
France	CH Pontoise - Centre Hospitalier René Dubos	Pontoise
France	Association AUB Santé Quimper	Quimper
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
French Polynesia	Association APURAD	Paéa

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Countries where clinical trial is conducted

France,  French Polynesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurence of bacterial peritonitis		24 months	Yes