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

NCT ID: NCT02255318

Last Updated: 2016-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2017-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cancer Infection

Keywords

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Taurolock® infections related to chambers implantable catheter patients with cancer receiving parenteral nutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Taurolock

Patients received Taurolock lock for 3 months administration.

Group Type EXPERIMENTAL

Taurolock

Intervention Type DEVICE

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Taurolock

Intervention Type DEVICE

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cécile CHAMBRIER, PH

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

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Hôpital Edouard Herriot

France, Lyon, France

Site Status RECRUITING

Hôpital de la Croix Rousse

France, , France

Site Status RECRUITING

Groupement Hospitalier Lyon Sud

Pierre-Bénite, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Cécile CHAMBRIER, PH

Role: CONTACT

Phone: 4.72 00 15 25

Email: [email protected]

Isabelle DELFOUR

Role: CONTACT

Phone: 4.26.73.27.25

Email: [email protected]

Facility Contacts

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Julien Forestier

Role: primary

Marielle GUILLET

Role: primary

Marion Chauvenet

Role: primary

Other Identifiers

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2013-792

Identifier Type: -

Identifier Source: org_study_id