NCT07183592

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

Impact of Infusion Line Change Frequency on Infectious Complications Related to Central Venous Catheters in the Intensive Care Unit ICU

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,830 (estimated)
• Sponsor: University Hospital, Angers · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Intensive Care (ICU)
• Central Venous Catheter Related Infections
• Critical Care Nursing
• Catheter-associated Bloodstream Infections (CLABSI)
• Nursing Workload

Interventions

Type	Name	Description
PROCEDURE	7-day Infusion set replacement	7-day infusion set replacement (Experimental arm) In this group, the infusion sets (the tubes and connectors used to deliver medications through the central venous catheter) will be changed once a week, every 7 days. During each replacement, all sets will be disconnected and replaced with new sterile ones.
PROCEDURE	4-day infusion set replacement	4-day infusion set replacement (Active comparator arm) In this group, the infusion sets will be changed every 4 days, which reflects the most common international recommendation. The procedure is the same: all sets connected to the central venous catheter will be replaced with new sterile ones. This strategy represents the current standard of care and will serve as the comparison for the 7-day approach.

Timeline

• Start date: 2026-04-01
• Primary completion: 2028-04-01
• Completion: 2028-10-01
• First posted: 2025-09-19
• Last updated: 2026-04-06

Locations

27 sites across 1 country: France