Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07183592

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

La Réunion University Hospital, Saint-Pierre, La Réunion, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

7-day Infusion set replacement

Procedure

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

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 outcomes

  1. 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).

    Infectious complications include:

    • 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.
    • 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

Secondary outcomes

  1. Central line-associated bloodstream infection (CLABSI)

    Time frame: Day 90

    Proportion of patients with central line-associated bloodstream infection

  2. Non-central line-associated bloodstream infection

    Time frame: Day 90

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

  3. 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).

    Proportion of catheters with catheter colonization

  4. Time to onset of central venous catheter-related infectious complication

    Time frame: Day 90

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

  5. ICU length of stay

    Time frame: Day 90

    Length of ICU stay

  6. All-cause ICU mortality

    Time frame: Day 90

    Number of patients who die from any cause during their ICU stay

  7. Cumulative nursing time related to infusion set replacements

    Time frame: 1000 days

    Total nursing time, measured in minutes, required to perform infusion set replacements, per 1000 catheter-days

  8. Cost of materials required for infusion set replacements

    Time frame: 1000 days

    Cost (euros) of materials required for infusion set replacements, per 1000 cathéter days

Study contacts

Contact information is provided by the study sponsor or research team.

Aurélie Hautefort

CONTACT

[email protected]

+332 41 35 58 99

Carole Haubertin

CONTACT

[email protected]

+332 41 35 40 82

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Registry information

Official study title

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

Acronym: TANDOORI

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 19, 2025
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.