Clinical trial · Interventional
Primary Prevention of Infections Related to Chambers Implantable Catheter by a Taurolodine Lock in Patients With Cancer Receiving Parenteral Nutrition
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Infection | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Drug | — | UNRESOLVED |
| Taurolock | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Taurolock
- description
- Patients received Taurolock lock for 3 months administration.
- interventionNames
- Device: Taurolock
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Patients received placebo lock (physiological serum) for 3 months administration.
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- 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.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available