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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Angers

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 7-day Infusion set replacement

    Procedure/Surgery

    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.

  • 4-day infusion set replacement

    Procedure/Surgery

    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.

Treatment groups

2,830 Participants
are divided into 2 treatment groups
Group A: 7-day infusion set replacementExperimental treatment 1 intervention
Group B: 4-day infusion set replacementActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Rate (%) of patients with with a central venous catheter-related infectious complication

Infectious complications include: 1. Catheter-related infections (CRI) defined as: * A positive catheter culture, with quantitative culture ≥10³ CFU/ml (Brun-Buisson technique) or, if not available, a semi-quantitative culture \>15 CFU (Maki technique), and purulence at the catheter insertion site or tunnelitis. Or * A positive catheter culture, with quantitative culture ≥10³ CFU/ml (or semi-quantitative culture \>15 CFU), and complete or partial regression of systemic signs of infection within 48 hours after catheter removal. 2. Catheter-related bloodstream infections (bacteremia or fungemia) defined as: * The occurrence of bacteremia (or fungemia) within 48 hours before or after catheter removal (or suspected catheter-related infection if the catheter is not immediately removed), And * Either a positive culture with the same microorganism from the insertion site or catheter, with ≥10³ CFU/ml (Brun-Buisson technique) or, if not available, a semi-quantitative culture

Time frame
From central venous catheter insertion until 48 hours after catheter removal during the ICU stay (censored at 90 days).

Secondary outcomes

1

Central line-associated bloodstream infection (CLABSI)

Proportion of patients with central line-associated bloodstream infection

Time frame
Day 90
2

Non-central line-associated bloodstream infection

Proportion of patients with non-central line-associated bloodstream infection

Time frame
Day 90
3

Catheters with catheter colonization

Proportion of 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).
4

Time to onset of central venous catheter-related infectious complication

Length of time (in days) before the onset of central venous catheter-related infectious complications

Time frame
Day 90

Other outcomes

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