Clinical trial NCT02255318: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer
Infection
Keywords: Taurolock®
infections related to chambers implantable catheter
patients with cancer receiving parenteral nutrition
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2014-10-02
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: 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.
timeFrame: The incidence will be assessed between the inclusion and 3 months after the beginning of the study.
Secondary outcomes:
measure: Delay onset of IRCIC
timeFrame: between the inclusion and 3 months after the beginning of the study
measure: Duration of hospitalizations for IRCIC.
timeFrame: between the inclusion and 3 months after the beginning of the study
Other outcomes:
Locations:
city: France
country: France
facility: Hôpital Edouard Herriot
state: Lyon
city: France
country: France
facility: Hôpital de la Croix Rousse
city: Pierre Bénite
country: France
facility: Groupement Hospitalier Lyon Sud
Study officials:
affiliation: Hospices Civils de Lyon
name: Cécile CHAMBRIER, PH
role: PRINCIPAL_INVESTIGATOR
References: