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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02255318
• Other study ID #: 2013-792
• Status: Recruiting
• Phase: N/A
• First received: September 30, 2014
• Last updated: October 27, 2016
• Start date: January 2015
• Est. completion date: May 2017

Study information

• Verified date: October 2016
• Source: Hospices Civils de Lyon
• Contact: Cécile CHAMBRIER, PH
• Phone: 4.72 00 15 25
• Email: cecile.chambrier[@]chu-lyon.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: May 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cancer
• Communicable Diseases
• Infection

Intervention

Device:
• Taurolock

Drug:
• Placebo

Locations

Country	Name	City	State
France	Hôpital de la Croix Rousse	France
France	Hôpital Edouard Herriot	France	Lyon
France	Groupement Hospitalier Lyon Sud	Pierre Bénite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	The incidence will be assessed between the inclusion and 3 months after the beginning of the study.	No
Secondary	Delay onset of IRCIC		between the inclusion and 3 months after the beginning of the study	No
Secondary	Duration of hospitalizations for IRCIC.		between the inclusion and 3 months after the beginning of the study	No