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

October 27, 2016 updated by: Hospices Civils de Lyon

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Taurolock
Patients received Taurolock lock for 3 months administration.
Device: Taurolock
PLACEBO_COMPARATOR: Placebo
Patients received placebo lock (physiological serum) for 3 months administration.
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: The incidence will be assessed between the inclusion and 3 months after the beginning of the study.
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.
The incidence will be assessed between the inclusion and 3 months after the beginning of the study.

Secondary Outcome Measures

Outcome Measure
Time Frame
Delay onset of IRCIC
Time Frame: between the inclusion and 3 months after the beginning of the study
between the inclusion and 3 months after the beginning of the study
Duration of hospitalizations for IRCIC.
Time Frame: between the inclusion and 3 months after the beginning of the study
between the inclusion and 3 months after the beginning of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Cécile CHAMBRIER, PH, Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (ANTICIPATED)

April 1, 2017

Study Completion (ANTICIPATED)

May 1, 2017

Study Registration Dates

First Submitted

September 30, 2014

First Submitted That Met QC Criteria

October 1, 2014

First Posted (ESTIMATE)

October 2, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

October 28, 2016

Last Update Submitted That Met QC Criteria

October 27, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-792

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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