Cancer Clinical Trial
Official title:
Primary Prevention of Infections Related to Chambers Implantable Catheter by a Taurolodine Lock in Patients With Cancer Receiving Parenteral Nutrition
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
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