RecruitingNAINTERVENTIONAL

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

This study, called a randomised controlled trial, is looking into how often we change the tubes used to give people medicines and fluids in intensive care units (ICU). These tubes are called central venous catheters. While these catheters are very important for treatment, they can sometimes lead to infections. We already have ways to prevent infections, but this study focuses on how often we replace the 'infusion sets' – the attached tubing that carries medicines to the catheter. Currently, many guidelines suggest changing these tubes every 4 days, but some say up to 7 days is acceptable. Changing them takes time for nurses and uses up medical supplies. The main goal of this study is to see if changing these tubes every 7 days is just as safe as changing them every 4 days in preventing infections, while also potentially reducing the workload on medical staff and saving resources.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital, Angers

Enrolment target

2,830

Start

12 May 2026

Estimated completion

01 Dec 2028

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

What is this study about?

Imagine you or a loved one is in an intensive care unit (ICU). Often, a special tube called a central venous catheter is put into a large vein, usually in the neck, chest, or groin. This tube is really important because it allows doctors and nurses to give vital medicines, fluids, and monitor your health around the clock. However, like any medical procedure, there's a small risk of complications, and one of the main concerns is infection. These infections, called 'catheter-associated bloodstream infections,' can be serious.

Most of the time, we focus on how these tubes are put in, how they're looked after, and how the dressing over them is changed. But another important part of preventing infection is how often the attached 'infusion sets' are changed. These are the long, thin tubes that connect the medicine bags to the central catheter. Over time, these tubes can get tiny germs on them, even if staff are very careful, and this could lead to infection. Regularly changing them helps to keep things clean and reduce this risk.

Currently, some guidelines suggest changing these infusion sets every 4 days, and others say it's okay to wait up to 7 days. Changing these sets takes time for busy nurses, uses special sterile equipment, and can be costly. This study aims to find out if extending the time between changes from 4 days to 7 days makes any difference to the risk of infection. If it doesn't increase infections, it could mean less work for nurses, fewer supplies used, and potentially still keep patients safe. The study wants to show that changing them every 7 days is just as safe as changing them every 4 days when it comes to preventing infections.

Key takeaways

The study wants to see if changing medicine tubes every 7 days is as safe as every 4 days.
It aims to reduce infection risk in ICU patients with central lines.
This could also help reduce workload for nurses and save resources.
Participation involves being randomly assigned to one of two tube-changing schedules.
Your medical care will otherwise remain the same.
You can stop participating at any time.

Who may be eligible?

This study is looking for adults who are currently in intensive care and have a central venous catheter place. This catheter must have been inserted within the last 3 days (72 hours) and doctors must expect that you will need this catheter for at least 7 more days. You also need to be part of a social security system.

There are several reasons why someone might *not* be able to take part. For example, if you already have a bloodstream infection, or if your catheter has been in for more than 3 days. Also, if there's any suspicion that your catheter is already causing an infection, you wouldn't be able to join. Patients who have specific health conditions, such as severe burns, certain blood clots, or skin issues at the catheter site, also cannot participate.

Other reasons for not taking part include if you have a known allergy to the catheter material, if you've already been part of this study during your current ICU stay, or if you are pregnant or breastfeeding. Patients who are unable to understand French, or who are under certain legal restrictions (like being in prison or under guardianship), also cannot be included.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you an adult patient in intensive care?
Do you have a central venous catheter that was put in less than 3 days ago?
Are doctors expecting you to need this catheter for at least another 7 days?
Do you currently not have a bloodstream infection?
Are you able to speak or understand French (or do you have someone who can explain things to you)?
Are you not pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you are eligible and agree to take part, you would be randomly placed into one of two groups. One group would have their infusion lines changed every 4 days, and the other group would have them changed every 7 days. This is the only difference in your care related to the study. Both groups will receive the standard excellent care you would expect in the intensive care unit. The study mainly involves medical staff simply following one of these two schedules for changing your infusion lines. You won't need any extra visits or special assessments just for the study. Doctors and nurses will continue to monitor your health and watch for any signs of infection, as they usually would, and this information will be used for the study. Your participation would last for as long as you have the central venous catheter in place during your ICU stay.

Potential risks and benefits

There is a potential benefit from this study, as it aims to improve understanding of how to best prevent infections in patients with central lines. For you personally, there are no direct proven benefits or risks beyond the standard care you would receive, as the study is comparing two accepted practices. However, medical research always has a small, unknown risk. You are free to withdraw from the study at any time without giving a reason, and this would not affect your medical care in any way.

Locations (27)

La Réunion University Hospital
Verified postcode
Saint-Pierre, France· Not yet recruiting
Albi Hospital
Verified postcode
Albi, France· Not yet recruiting
Angers University Hospital
Verified postcode
Angers, France· Recruiting
Belfort Hospital
Verified postcode
Belfort, France· Not yet recruiting
Bourges Hospital
Verified postcode
Bourges, France· Not yet recruiting
Caen University Hospital
Verified postcode
Caen, France· Not yet recruiting
CH Carcassonne
Verified postcode
Carcassonne, France· Not yet recruiting
Chartres Hospital
Verified postcode
Chartres, France· Not yet recruiting
Cholet Hospital
Verified postcode
Cholet, France· Not yet recruiting
Colombes Hospital
Verified postcode
Colombes, France· Not yet recruiting
Corbeil-Essonnes Hospital
Verified postcode
Corbeil-Essonnes, France· Not yet recruiting
AP-HP - Henri Mondor Hospital
Verified postcode
Créteil, France· Not yet recruiting

Common questions

What is a central venous catheter?

It's a tube placed into a large vein to give medicines and fluids, and to monitor your health, often used in intensive care.

What are infusion sets?

These are the smaller tubes that connect your medicine bags to the central venous catheter.

Why is this study important?

It helps us understand the best way to change these tubes to prevent infections, which could lead to safer care for patients in the ICU.

Will my care change if I join the study?

The only difference in your care will be if your infusion tubes are changed every 4 or 7 days, as decided randomly by the study. Otherwise, your medical care remains the same.

Can I leave the study at any time?

Yes, completely. You can decide to leave the study at any point, and it won't affect your medical care.

How to find out more

Carole Haubertin

carole.haubertin@chu-angers.fr +332 41 35 40 82 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.