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Primary Prevention of Infections Related to Chambers Implantable Catheter by a Taurolodine Lock in Patients With Cancer Receiving Parenteral Nutrition

Primary Purpose

Cancer, Infection

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Taurolock
Placebo
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cancer focused on measuring Taurolock®, infections related to chambers implantable catheter, patients with cancer receiving parenteral nutrition

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients aged 18 years and over
  • Patients with solid cancer
  • Patients with implantable catheter
  • Patients receiving parenteral nutrition
  • Patient affiliated to a social security scheme or beneficiary of such a regime

Exclusion Criteria:

  • Patients refusing to participate in the protocol
  • Patients already receiving preventive lock of IRCIC
  • Known citrate or (cyclo) allergy -taurolidine
  • Patients taking other drugs with known contraindications against the citrate or cyclotaurolidine.
  • Participation in another protocol for the prevention of infections associated with central venous catheters
  • Patients who did not sign the consent
  • Patient with a status of socio-legal protection

Sites / Locations

  • Hôpital Edouard HerriotRecruiting
  • Hôpital de la Croix RousseRecruiting
  • Groupement Hospitalier Lyon SudRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Taurolock

Placebo

Arm Description

Patients received Taurolock lock for 3 months administration.

Patients received placebo lock (physiological serum) for 3 months administration.

Outcomes

Primary Outcome Measures

The incidence rate of infections related to chamber implantable catheters (IRCIC) in patients who received Taurolock® versus those who received the usual procedure of saline flush.
Definition of IRCIC This definition of infections related to chamber implantable catheters will be used for all patients. It is based on the identification of the same germ blood cultures of peripheral vein and those of the central venous line with a differential time greater than 120 minutes growth.

Secondary Outcome Measures

Delay onset of IRCIC
Duration of hospitalizations for IRCIC.

Full Information

First Posted
September 30, 2014
Last Updated
October 27, 2016
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT02255318
Brief Title
Primary Prevention of Infections Related to Chambers Implantable Catheter by a Taurolodine Lock in Patients With Cancer Receiving Parenteral Nutrition
Official Title
Primary Prevention of Infections Related to Chambers Implantable Catheter by a Taurolodine Lock in Patients With Cancer Receiving Parenteral Nutrition
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
April 2017 (Anticipated)
Study Completion Date
May 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The therapeutic management of patients with cancer often requires the establishment of a chamber implantable catheter. Infections are the main complication of these catheters. These infections may be responsible for a significant impairment of quality of life for patients, and may increase the frequency and duration of hospitalizations. The rate of mortality from these infections is about 17%. The objective of this study is to evaluate the efficacy of a 1.35% taurolidine lock / 4% citrate (TauroLock®) in the primary prevention of infections related to chambers implantable catheter (IRCIC) in cancer patients receiving parenteral nutrition. This is a, randomized, double-blind clinical trial comparing the incidence of IRCIC in patients receiving Taurolidine lock or concession the usual procedure of rinsing with saline (placebo) (pulsed rinsing with 20 mL of serum physiological and clamping catheter positive pressure). The lock will be instilled after the end of the session IV treatment (chemotherapy, parenteral nutrition, transfusion) before closing the catheter. The primary endpoint will be the rate IRCIC in both groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Infection
Keywords
Taurolock®, infections related to chambers implantable catheter, patients with cancer receiving parenteral nutrition

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Taurolock
Arm Type
Experimental
Arm Description
Patients received Taurolock lock for 3 months administration.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients received placebo lock (physiological serum) for 3 months administration.
Intervention Type
Device
Intervention Name(s)
Taurolock
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
The incidence rate of infections related to chamber implantable catheters (IRCIC) in patients who received Taurolock® versus those who received the usual procedure of saline flush.
Description
Definition of IRCIC This definition of infections related to chamber implantable catheters will be used for all patients. It is based on the identification of the same germ blood cultures of peripheral vein and those of the central venous line with a differential time greater than 120 minutes growth.
Time Frame
The incidence will be assessed between the inclusion and 3 months after the beginning of the study.
Secondary Outcome Measure Information:
Title
Delay onset of IRCIC
Time Frame
between the inclusion and 3 months after the beginning of the study
Title
Duration of hospitalizations for IRCIC.
Time Frame
between the inclusion and 3 months after the beginning of the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients aged 18 years and over Patients with solid cancer Patients with implantable catheter Patients receiving parenteral nutrition Patient affiliated to a social security scheme or beneficiary of such a regime Exclusion Criteria: Patients refusing to participate in the protocol Patients already receiving preventive lock of IRCIC Known citrate or (cyclo) allergy -taurolidine Patients taking other drugs with known contraindications against the citrate or cyclotaurolidine. Participation in another protocol for the prevention of infections associated with central venous catheters Patients who did not sign the consent Patient with a status of socio-legal protection
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cécile CHAMBRIER, PH
Phone
4.72 00 15 25
Ext
+33
Email
cecile.chambrier@chu-lyon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Isabelle DELFOUR
Phone
4.26.73.27.25
Ext
+33
Email
isabelle.delfour@chu-lyon.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cécile CHAMBRIER, PH
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Edouard Herriot
City
France
State/Province
Lyon
ZIP/Postal Code
69003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julien Forestier
Email
julien.forestier@chu-lyon.fr
Facility Name
Hôpital de la Croix Rousse
City
France
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marielle GUILLET
Email
marielle.guillet@chu-lyon.fr
Facility Name
Groupement Hospitalier Lyon Sud
City
Pierre Bénite
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marion Chauvenet
Email
marion.chauvenet@chu-lyon.fr

12. IPD Sharing Statement

Learn more about this trial

Primary Prevention of Infections Related to Chambers Implantable Catheter by a Taurolodine Lock in Patients With Cancer Receiving Parenteral Nutrition

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