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

Civil Hospices of Lyon

Status: Unknown

Conditions: Infection; Cancer

Treatments: Device: Taurolock; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02255318

2013-792

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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70 participants in 2 patient groups, including a placebo group

Taurolock

Experimental group

Description:

Patients received Taurolock lock for 3 months administration.

Treatment:

Device: Taurolock

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo