Primary Prevention of Infections Related to Chambers Implantable Catheter by a Taurolodine Lock in Patients With Cancer Receiving Parenteral Nutrition
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|ClinicalTrials.gov Identifier: NCT02255318|
Recruitment Status : Unknown
Verified October 2016 by Hospices Civils de Lyon.
Recruitment status was: Recruiting
First Posted : October 2, 2014
Last Update Posted : October 28, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Cancer Infection||Device: Taurolock Drug: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Primary Prevention of Infections Related to Chambers Implantable Catheter by a Taurolodine Lock in Patients With Cancer Receiving Parenteral Nutrition|
|Study Start Date :||January 2015|
|Estimated Primary Completion Date :||April 2017|
|Estimated Study Completion Date :||May 2017|
Patients received Taurolock lock for 3 months administration.
Placebo Comparator: Placebo
Patients received placebo lock (physiological serum) for 3 months administration.
- 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. [ Time Frame: The incidence will be assessed between the inclusion and 3 months after the beginning of the study. ]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.
- Delay onset of IRCIC [ Time Frame: between the inclusion and 3 months after the beginning of the study ]
- Duration of hospitalizations for IRCIC. [ Time Frame: between the inclusion and 3 months after the beginning of the study ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02255318
|Contact: Cécile CHAMBRIER, PH||4.72 00 15 25 ext +email@example.com|
|Contact: Isabelle DELFOUR||126.96.36.199.25 ext +firstname.lastname@example.org|
|Hôpital Edouard Herriot||Recruiting|
|France, Lyon, France, 69003|
|Contact: Julien Forestier email@example.com|
|Hôpital de la Croix Rousse||Recruiting|
|Contact: Marielle GUILLET firstname.lastname@example.org|
|Groupement Hospitalier Lyon Sud||Recruiting|
|Pierre Bénite, France|
|Contact: Marion Chauvenet email@example.com|
|Principal Investigator:||Cécile CHAMBRIER, PH||Hospices Civils de Lyon|