Taurolock for Preventing Bacterial Peritonitis During Renal Insufficiency

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01101087
Recruitment Status : Completed
First Posted : April 9, 2010
Last Update Posted : December 18, 2015
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Peritonitis Catheter-related Infections Renal Insufficiency Device: Taurolock Other: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
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 : July 2010
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

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.

Primary Outcome Measures :
  1. Occurence of bacterial peritonitis [ Time Frame: 24 months ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01101087

CHU de Nîmes - Hôpital Universitaire Carémeau
Nimes, Gard, France, 30029
CH d'Avignon - Centre Hospitalier Henri Duffaut
Avignon, France, 84902
CHU de Caen - Hôpital Clemenceau
Caen, France, 14033
CH de Chambéry
Chambery, France, 73011
CH de Colmar - Hôpitaux Civils de Colmar
Colmar, France, 68024
Association CALYDIAL Vienne
Irigny, France, 69540
Centre Hospitalier Départemental Vendée - Site de la Roche sur Yon
La Roche sur Yon, France, 85925
AIDER - Clinque Jacques Mirouze
Montpellier, France, 34295
APHP - Groupe Hospitalier Pitié-Salpetrière
Paris, France, 75651
CH Pontoise - Centre Hospitalier René Dubos
Pontoise, France, 95300
Association AUB Santé Quimper
Quimper, France, 29000
Centre Hospitalier Regional - Site Groupe Hospitalier Sud Réunion (GHSR)
Saint Pierre, France, 97448
CH de Valenciennes - Hôpital Jean Bernard et Hôtel Dieu
Valenciennes, France, 59322
ALTIR - Hôpital Brabois
Vandoeuvre les Nancy Cedex, France, 54504
French Polynesia
Association APURAD
Paéa, French Polynesia, 98711
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Principal Investigator: Bernard Branger, MD Centre Hospitalier Universitaire de Nîmes

Responsible Party: Centre Hospitalier Universitaire de Nīmes Identifier: NCT01101087     History of Changes
Other Study ID Numbers: PHRC-N/2009/BB
2009-A00599-48 ( Other Identifier: RCB number )
First Posted: April 9, 2010    Key Record Dates
Last Update Posted: December 18, 2015
Last Verified: December 2015

Keywords provided by Centre Hospitalier Universitaire de Nīmes:

Additional relevant MeSH terms:
Renal Insufficiency
Catheter-Related Infections
Kidney Diseases
Urologic Diseases
Intraabdominal Infections
Peritoneal Diseases
Digestive System Diseases