NCT01101087

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 8, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 9, 2010

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

December 18, 2015

Status Verified

December 1, 2015

Enrollment Period

5.4 years

First QC Date

April 8, 2010

Last Update Submit

December 17, 2015

Conditions

PeritonitisCatheter-related InfectionsRenal Insufficiency

Keywords

Dialysis

Outcome Measures

Primary Outcomes (1)

  • Occurence of bacterial peritonitis

    24 months

Study Arms (2)

Taurolock

EXPERIMENTAL
Device: Taurolock

Placebo

PLACEBO COMPARATOR
Other: Placebo

Interventions

TaurolockDEVICE
Taurolock
PlaceboOTHER

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

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or older
  • Renal insufficiency, stage V (HAS 2007 classification)
  • Requires incident peritoneal dialysis
  • signed consent
  • affiliated with a social security system

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, Gard, 30029, France

Location

CH d'Avignon - Centre Hospitalier Henri Duffaut

Avignon, 84902, France

Location

CHU de Caen - Hôpital Clemenceau

Caen, 14033, France

Location

CH de Chambéry

Chambéry, 73011, France

Location

CH de Colmar - Hôpitaux Civils de Colmar

Colmar, 68024, France

Location

Association CALYDIAL Vienne

Irigny, 69540, France

Location

Centre Hospitalier Départemental Vendée - Site de la Roche sur Yon

La Roche-sur-Yon, 85925, France

Location

AIDER - Clinque Jacques Mirouze

Montpellier, 34295, France

Location

APHP - Groupe Hospitalier Pitié-Salpetrière

Paris, 75651, France

Location

CH Pontoise - Centre Hospitalier René Dubos

Pontoise, 95300, France

Location

Association AUB Santé Quimper

Quimper, 29000, France

Location

Centre Hospitalier Regional - Site Groupe Hospitalier Sud Réunion (GHSR)

Saint-Pierre, 97448, France

Location

CH de Valenciennes - Hôpital Jean Bernard et Hôtel Dieu

Valenciennes, 59322, France

Location

ALTIR - Hôpital Brabois

Vandœuvre-lès-Nancy, 54504, France

Location

Association APURAD

Paéa, 98711, French Polynesia

Location

MeSH Terms

Conditions

PeritonitisCatheter-Related InfectionsRenal Insufficiency

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsPeritoneal DiseasesDigestive System DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Bernard Branger, MD

    Centre Hospitalier Universitaire de Nîmes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2010

First Posted

April 9, 2010

Study Start

July 1, 2010

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

December 18, 2015

Record last verified: 2015-12

Locations

FR(1)