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

Official title

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

Overview

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.

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.

Primary outcome measures

• Rate (%) of patients with with a central venous catheter-related infectious complication [Time frame: From central venous catheter insertion until 48 hours after catheter removal during the ICU stay (censored at 90 days).]

Secondary outcome measures (8)

• Central line-associated bloodstream infection (CLABSI) [Time frame: Day 90]
• Non-central line-associated bloodstream infection [Time frame: Day 90]
• Catheters with catheter colonization [Time frame: From central venous catheter insertion until 48 hours after catheter removal during the ICU stay (censored at 90 days).]
• Time to onset of central venous catheter-related infectious complication [Time frame: Day 90]
• ICU length of stay [Time frame: Day 90]
• All-cause ICU mortality [Time frame: Day 90]
• Cumulative nursing time related to infusion set replacements [Time frame: 1000 days]
• Cost of materials required for infusion set replacements [Time frame: 1000 days]

Eligibility criteria

Inclusion criteria

• Adult patient
• Any ICU patient with a central venous catheter (inserted by venipuncture) in place for less than 72 hours and with an expected dwell time of at least 7 days
• Patient affiliated with or covered by a social security system
• Patient who has given verbal consent or written consent from a third party or in the event that the patient is unable to give consent.

Exclusion criteria

• Patient with a documented bloodstream infection at the time of inclusion
• Patient whose central venous catheter has been in place for more than 72 hours
• Patient with suspected catheter-related infection
• Patient whose study catheter was inserted using a guidewire exchange
• Patient previously enrolled in the study during the same ICU stay
• Patient whose condition, according to the clinician, does not allow safe placement of a central venous catheter, such as:

• Allergy to catheter material
• Confirmed deep vein thrombosis at the time of insertion
• Inflammatory skin disorder at the insertion site
• Patient admitted for extensive burns
• Inadequate understanding of the French language
• Pregnant, breastfeeding, or postpartum woman
• Person deprived of liberty by judicial or administrative decision
• Person receiving involuntary psychiatric care
• Person under legal guardianship or other legal protection measure

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Health services research

Study locations

France · 27 centers

• La Réunion University Hospital — Saint-Pierre
• Albi Hospital — Albi
• Angers University Hospital — Angers
• Belfort Hospital — Belfort
• Bourges Hospital — Bourges
• Caen University Hospital — Caen
• CH Carcassonne — Carcassonne
• Chartres Hospital — Chartres
• … and 19 more centers

Identifiers

NCT: NCT07183592 · 49RC24_0290 · 2025-A01509-40

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗