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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
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief 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.


Condition or disease Intervention/treatment Phase
Cancer Infection Device: Taurolock Drug: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
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

Arm Intervention/treatment
Experimental: Taurolock
Patients received Taurolock lock for 3 months administration.
Device: Taurolock
Placebo Comparator: Placebo
Patients received placebo lock (physiological serum) for 3 months administration.
Drug: Placebo



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Delay onset of IRCIC [ Time Frame: between the inclusion and 3 months after the beginning of the study ]
  2. Duration of hospitalizations for IRCIC. [ Time Frame: between the inclusion and 3 months after the beginning of the study ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Cécile CHAMBRIER, PH 4.72 00 15 25 ext +33 cecile.chambrier@chu-lyon.fr
Contact: Isabelle DELFOUR 4.26.73.27.25 ext +33 isabelle.delfour@chu-lyon.fr

Locations
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France
Hôpital Edouard Herriot Recruiting
France, Lyon, France, 69003
Contact: Julien Forestier       julien.forestier@chu-lyon.fr   
Hôpital de la Croix Rousse Recruiting
France, France
Contact: Marielle GUILLET       marielle.guillet@chu-lyon.fr   
Groupement Hospitalier Lyon Sud Recruiting
Pierre Bénite, France
Contact: Marion Chauvenet       marion.chauvenet@chu-lyon.fr   
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Cécile CHAMBRIER, PH Hospices Civils de Lyon
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02255318    
Other Study ID Numbers: 2013-792
First Posted: October 2, 2014    Key Record Dates
Last Update Posted: October 28, 2016
Last Verified: October 2016
Keywords provided by Hospices Civils de Lyon:
Taurolock®
infections related to chambers implantable catheter
patients with cancer receiving parenteral nutrition
Additional relevant MeSH terms:
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Infection
Communicable Diseases