Impact of Infusion Line Change Frequency on Infectious Complications Related to Central Venous Ca… (NCT07183592) | Clinical Trial Compass
RecruitingNot Applicable
Impact of Infusion Line Change Frequency on Infectious Complications Related to Central Venous Catheters in the ICU - A Randomized Controlled Trial
France2,830 participantsStarted 2026-05-12
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rate (%) of patients with with a central venous catheter-related infectious complication
Timeframe: From central venous catheter insertion until 48 hours after catheter removal during the ICU stay (censored at 90 days).