Impact of Early Enteral vs. Parenteral Nutrition on Mortality in Patients Requiring Mechanical Ventilation and Catecholamines
NCT01802099
Acute Respiratory Failure, Cross Infection
Amiens, France
View Trial DetailsNCT Number: NCT07259421
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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Proportion of patients for whom lock solutions are withdrawn in accordance with the manufacturer's instructions for use (lock solutions aspirated before catheter use).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.
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.
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.
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.
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).
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.
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.
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.
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.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Aida MANDZO, clinical research associate
CONTACT
Cordélia SALOMEZ-IHL, pharmacist
CONTACT
University Hospital, Grenoble
Other
Acronym: TAURO-USE2
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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