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NOT YET RECRUITING
NCT07183592
NA

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

Sponsor: University Hospital, Angers

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

2830

Start Date

2026-04

Completion Date

2028-10

Last Updated

2026-04-06

Healthy Volunteers

No

Interventions

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.

Locations (27)

La Réunion University Hospital

Saint-Pierre, La Réunion, France

Albi Hospital

Albi, France

Angers University Hospital

Angers, France

Belfort Hospital

Belfort, France

Bourges Hospital

Bourges, France

Caen University Hospital

Caen, France

CH Carcassonne

Carcassonne, France

Chartres Hospital

Chartres, France

Cholet Hospital

Cholet, France

Colombes Hospital

Colombes, France

Corbeil-Essonnes Hospital

Corbeil-Essonnes, France

AP-HP - Henri Mondor Hospital

Créteil, France

Dijon University Hospital

Dijon, France

Garches Hospital

Garches, France

CH Le Mans

Le Mans, France

Le Puy en Velay Hospital

Le Puy-en-Velay, France

Macon Hospital

Mâcon, France

Nantes University Hospital

Nantes, France

Orleans University Hospital

Orléans, France

AP-HP - Tenon Hospital

Paris, France

AP-HP - Saint Louis

Paris, France

Pontoise Hospital

Pontoise, France

CHU Rennes - service MIR

Rennes, France

CHU Rennes - service Réa chir

Rennes, France

CH Saint-Nazaire

Saint-Nazaire, France

Strasbourg University Hospital

Strasbourg, France

CHU Tours

Tours, France