NCT02255318

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cancer
• Infection

Interventions

Type	Name	Description
DEVICE	Taurolock
DRUG	Placebo

Timeline

• Start date: 2015-01-01
• Primary completion: 2017-04-01
• Completion: 2017-05-01
• First posted: 2014-10-02
• Last updated: 2016-10-28

Locations

3 sites across 1 country: France