- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07259421
Survey of Practices Regarding the Use of Taurolidine Lock Solutions in Patients With Insertion of a Peripherally Inserted Central Catheter (PICC) in a Vascular Access Unit (TAURO-USE2)
The primary objective of this study is to describe current practices regarding the administration of taurolidine lock solutions in relation to medical prescriptions for patients who have undergone peripherally inserted central catheter (PICC) implantation in the Vascular Access Unit as part of parenteral nutrition therapy. Our underlying hypothesis is that the use of taurolidine lock solutions may deviate from current recommendations, particularly with respect to administration procedures.
This study will allow us to characterize the use of taurolidine lock solutions in relation to medical prescriptions, identify potential deviations from recommended practices, and document any associated adverse events. It will also enable follow-up of PICC outcomes at 8 and 30 days after implantation in the Vascular Access Unit, whereas current follow-up is performed only at 8 days post-insertion.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Cordélia SALOMEZ-IHL, pharmacist
- Phone Number: + 33 (0)4 76 76 85 27
- Email: cihl@chu-grenoble.fr
Study Contact Backup
- Name: Aida MANDZO, clinical research associate
- Phone Number: +33 (0)4 76 76 68 16
- Email: amandzo@chu-grenoble.fr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patient who has undergone PICC placement in the vascular access unit with an indication for parenteral nutrition supplementation.
- Patient not opposed to participating in this research.
Exclusion Criteria:
- Patient not speaking French
- Patient under guardianship or conservatorship
- Patient with major neurocognitive disorders
- Patient with severe hearing impairment
- Patient who do not have a telephone
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To characterize, through an assessment of current practices, the administration of taurolidine lock solutions as prescribed for patients who have undergone PICC implantation in the Vascular Access Unit as part of parenteral nutrition therapy.
Time Frame: Eight and thirty days after PICC placement in the Vascular Access Unit
|
Proportion of patients with a prescription for a taurolidine lock solution who actually receive administrations of the prescribed lock solution (concordance between prescribed and administered product). Proportion of patients for whom lock solutions are administered in accordance with the manufacturer's instructions for use; compliant administration is defined as the nurse performing all recommended steps for applying the lock solution at the end of each parenteral nutrition infusion. Proportion of patients for whom lock solutions are withdrawn in accordance with the manufacturer's instructions for use (lock solutions aspirated before catheter use). Proportion of patients for whom lock solutions are disposed of in accordance with regulations for biological-hazard waste. |
Eight and thirty days after PICC placement in the Vascular Access Unit
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Describe nurses' perceptions of their own knowledge regarding the use of taurolidine lock solutions.
Time Frame: Eight and thirty days after PICC placement in the Vascular Access Unit.
|
Quantify, using a self-assigned score, nurses' level of knowledge concerning taurolidine lock solutions. Proportion of nurses aware of the various properties of lock solutions according to the references available on the market. |
Eight and thirty days after PICC placement in the Vascular Access Unit.
|
|
Describe the medical care provided by home service providers for patients receiving a PICC placement for parenteral nutrition supplementation.
Time Frame: Eight and thirty days after PICC placement in the Vascular Access Unit.
|
Nature and number of service providers working with patients at home.
|
Eight and thirty days after PICC placement in the Vascular Access Unit.
|
|
Describe the supply chain for taurolidine lock solutions.
Time Frame: Eight and thirty days after PICC placement in the Vascular Access Unit.
|
Nature and proportions of procurement methods for taurolidine lock solutions for patients at home.
|
Eight and thirty days after PICC placement in the Vascular Access Unit.
|
|
Describe the elements related to PICC placement.
Time Frame: Eight and thirty days after PICC placement in the Vascular Access Unit.
|
Nature and proportions of elements related to PICC placement: number of lumens, vein of insertion, side of insertion, duration of placement, and role of the inserter (nurse anesthetists or physician).
|
Eight and thirty days after PICC placement in the Vascular Access Unit.
|
|
Characterize the functional status of the PICC over time.
Time Frame: Eight and thirty days after PICC placement in the Vascular Access Unit.
|
Proportion of PICC in place and functional at 8 and 30 days post-insertion, defined as not requiring premature removal and allowing infusion and blood sampling.
|
Eight and thirty days after PICC placement in the Vascular Access Unit.
|
|
Describe complications related to PICC placement.
Time Frame: Eight and thirty days after PICC placement in the Vascular Access Unit.
|
Nature and proportions of complications related to the PICC occurring within 8 and 30 days post-insertion.
|
Eight and thirty days after PICC placement in the Vascular Access Unit.
|
|
Describe the causes of premature PICC removal.
Time Frame: Eight and thirty days after PICC placement in the Vascular Access Unit.
|
Nature and proportions of causes for premature PICC-line removal within 8 and 30 days post-insertion.
|
Eight and thirty days after PICC placement in the Vascular Access Unit.
|
|
Describe adverse events related to the use of taurolidine lock solutions.
Time Frame: Eight and thirty days after PICC placement in the Vascular Access Unit.
|
Nature and proportion of adverse events potentially related to the use of a taurolidine lock solution, as reported by patients or healthcare providers.
|
Eight and thirty days after PICC placement in the Vascular Access Unit.
|
|
Describe the difficulties encountered by healthcare professionals when using taurolidine lock solutions.
Time Frame: Eight and thirty days after PICC placement in the Vascular Access Unit.
|
Nature and proportion of difficulties encountered by home-care nurses when using taurolidine lock solutions.
|
Eight and thirty days after PICC placement in the Vascular Access Unit.
|
|
Describe the information sources used by healthcare professionals regarding taurolidine lock solutions.
Time Frame: Eight and thirty days after PICC placement in the Vascular Access Unit.
|
Nature and proportion of information sources consulted by nurses in the event of problems related to the use of a taurolidine lock solution or to the use of the PICC.
|
Eight and thirty days after PICC placement in the Vascular Access Unit.
|
|
Characterize the use of device vigilance in the event of adverse events related to taurolidine lock solutions.
Time Frame: Eight and thirty days after PICC placement in the Vascular Access Unit.
|
Proportion of nurses who would report to device vigilance any adverse events related to the use of a taurolidine lock solution or to the use of the PICC, should such events occur.
|
Eight and thirty days after PICC placement in the Vascular Access Unit.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 38RC25.0315.
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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