Clinical Trial

Impact of Infusion Line Change Frequency on Infectious Complications Related to Central Venous Catheters in the ICU - A Randomized Controlled Trial

Study acronym: TANDOORI
Recruiting
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Summary
In the intensive care unit, patients' care and secure drugs administration require a central venous catheter. These invasive devices can lead to complications, particularly infections. Most preventive recommendations focus on catheter insertion, line handling, and dressings. Few recommendations adress catheter dwell time, which is certainly the main source of infection. Part of the prevention strategy is the regular and systematic replacement of infusion sets , as they may become contaminated during use, mainly through the hands of healthcare professionals. Prolonged use increases the risk of infection. Infusion lines changes involve disconnecting the old sets, discarding infusion devices containing drug residues, and replacing them with new sterile devices. Current international guidelines recommend replacing these sets every 4 days, and the Center for Disease Control and Prevention recommends not exceeding 7 days. Replacing these devices requires the time of qualified nurses, numerous sterile medical devices, and medications. In addition to the intended effect on infection prevention, the procedure has impacts on workload and costs. The objective of the study is to demonstrate that changing infusion set every 7 days does not increase the rate of central venous catheters related infections compared with changing infusion set every 4 days.
Protocol Amendment History 3 changes
critical Recruitment opened 2026-05-14
notable Primary completion pushed: 2028-04 -> 2028-05 2026-05-14
minor Completion pushed: 2028-10 -> 2028-12 2026-05-14
Trial Details
NCT Number NCT07183592
Lead Sponsor University Hospital, Angers
Conditions Intensive Care (ICU), Central Venous Catheter Related Infections, Critical Care Nursing, Catheter-associated Bloodstream Infections (CLABSI), Nursing Workload
Enrollment 2,830 participants
Start Date 2026-05-12
Primary Completion 2028-05 (estimated)
Study Completion 2028-12 (estimated)
Updated on ClinicalTrials.gov 2026-05-13