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

Not Applicable

• Conditions: Cancer; Infection
• Interventions: Drug: Placebo; Device: Taurolock

• Registration Number: NCT02255318
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-09-30
• Study First Submitted QC: 2014-10-01
• Study First Posted: 2014-10-02
• Study Start: 2015-01
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-27
• Last Update Posted: 2016-10-28
• Primary Completion: 2017-04
• Study Completion: 2017-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Patients received placebo lock (physiological serum) for 3 months administration.
Taurolock	Taurolock	Patients received Taurolock lock for 3 months administration.

Primary Outcome Measures

Name	Time	Method
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.	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.

Secondary Outcome Measures

Name	Time	Method
Duration of hospitalizations for IRCIC.	between the inclusion and 3 months after the beginning of the study
Delay onset of IRCIC	between the inclusion and 3 months after the beginning of the study

Trial Locations

Locations (3)

Hôpital Edouard Herriot; 🇫🇷 France, Lyon, France

Groupement Hospitalier Lyon Sud; 🇫🇷 Pierre Bénite, France

Hôpital de la Croix Rousse; 🇫🇷 France, France