Informations générales (source: ClinicalTrials.gov)
Primary Prevention of Infections Related to Chambers Implantable Catheter by a Taurolodine Lock in Patients With Cancer Receiving Parenteral Nutrition
Interventional
N/A
Hospices Civils de Lyon (Voir sur ClinicalTrials)
janvier 2015
mai 2017
29 juin 2024
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.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Groupement Hospitalier Lyon Sud - Pierre Bénite - France | Marion Chauvenet | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Hôpital de la Croix Rousse - France - France | Marielle GUILLET | Contact (sur clinicalTrials) | |||
| Hôpital Edouard Herriot - 69003 - France - Lyon - France | Julien Forestier | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- 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
- 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