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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Taurolock | Experimental | Patients received Taurolock lock for 3 months administration. |
|
| Placebo | Placebo Comparator | Patients received placebo lock (physiological serum) for 3 months administration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Taurolock | Device |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Delay onset of IRCIC | between the inclusion and 3 months after the beginning of the study | |
| Duration of hospitalizations for IRCIC. | between the inclusion and 3 months after the beginning of the study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cécile CHAMBRIER, PH | Contact | 4.72 00 15 25 | +33 | cecile.chambrier@chu-lyon.fr |
| Isabelle DELFOUR | Contact | 4.26.73.27.25 | +33 | isabelle.delfour@chu-lyon.fr |
| Name | Affiliation | Role |
|---|---|---|
| Cécile CHAMBRIER, PH | Hospices Civils de Lyon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Edouard Herriot | Recruiting | France | Lyon | 69003 | France |
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|
| Hôpital de la Croix Rousse | Recruiting | France | France |
|
| Groupement Hospitalier Lyon Sud | Recruiting | Pierre-Bénite | France |
|
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D007239 | Infections |
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