Intensive Care (ICU)TANDOORINCT07183592
Impact of Infusion Line Change Frequency on Infectious Complications Related to Central Venous Catheters in the ICU - A Randomized Controlled Trial
A study testing 7-day Infusion set replacement and 4-day infusion set replacement in people with Intensive Care (ICU) and Central Venous Catheter Related Infections, run by University Hospital, Angers at 27 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care (ICU), Central Venous Catheter Related Infections, Critical Care Nursing
- What is being tested?
- 7-day Infusion set replacement and 4-day infusion set replacement
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,830 participants
- Where
- 27 sitesFrance
- Study dates
- 12 May 2026to Dec 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
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- 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
Trial locations and contacts
27 sites in 1 country. Contact the study team or a site near you to ask about taking part.
27 sites in 1 country
France27 sites, 27 recruiting
- Not yet recruiting
Albi Hospital
Albi, 81000
Simon Gayrard, +33563480653, simon.gayrard@ch-albi.fr
- Recruiting
Angers University Hospital
Angers, 49933
Carole Haubertin, +332 41 35 40 82
- Not yet recruiting
Belfort Hospital
Belfort, 90015
Nahila Himer, +33384983573, Nahila.HIMER@hnfc.fr
- Not yet recruiting
Bourges Hospital
Bourges, 18000
Anna Bourreau, +33248484848, anna.bourreau@ch-bourges.fr
- Not yet recruiting
Caen University Hospital
Caen, 14033
Agathe Hamelin, +33231064711, hamelin-a@chu-caen.fr
- Not yet recruiting
CH Carcassonne
Carcassonne, 11000
Cécile LORY, 0468242384, cecile.lory@chcarcassonne.fr
- Not yet recruiting
Chartres Hospital
Chartres
Justine Clavelou, +332 37 30 30 30, clavelou.justine@gmail.com
- Not yet recruiting
Cholet Hospital
Cholet, 49300
Charlotte Debarre, +332414966398, charlotte.debarre@ch-cholet.fr
- Not yet recruiting
Colombes Hospital
Colombes, 92700
Blandine Dutrech, +33147606833, blandine.bourreau-gueriniere@aphp.fr
- Not yet recruiting
Corbeil-Essonnes Hospital
Corbeil-Essonnes, 91106
Justine Nunes, +33161695007, justine.nunes@chsf.fr
- Not yet recruiting
AP-HP - Henri Mondor Hospital
Créteil, 94000
Marianne Le Joncour, +331 49 81 24 36, marianne.lejoncour@aphp.fr
- Not yet recruiting
Dijon University Hospital
Dijon, 21079
Jean-Pierre Quenot, +333 85 27 54 10, jean-pierre.quenot@chu-dijon.fr
- Not yet recruiting
Garches Hospital
Garches
Segolene Jourdier, +33147107778, segolene.jourdier@aphp.fr
- Not yet recruiting
CH Le Mans
Le Mans, 72000
Aurélie BRASSELET, 0243432765, abrasselet@ch-lemans.fr
- Not yet recruiting
Le Puy en Velay Hospital
Le Puy-en-Velay, 43000
Isabelle Roure, +33471043537, isabelle.roure@ch-lepuy.fr
- Not yet recruiting
Macon Hospital
Mâcon, 71000
Marine Alissant, +33380293685, maalissant@ch-macon.fr
- Not yet recruiting
Nantes University Hospital
Nantes, 44093
Jerome Dauvergne, +332 40 16 52 84, jerome.dauvergne@chu-nantes.fr
- Not yet recruiting
Orleans University Hospital
Orléans, 45067
Amandine Thiery, +332 38 51 44 46, amandine.thiery@chu-orleans.fr
- Not yet recruiting
AP-HP - Tenon Hospital
Paris, 75020
Guillaume Voiriot, +331 56 01 55 98, guillaume.voiriot@aphp.fr
- Not yet recruiting
AP-HP - Saint Louis
Paris, 75475
Julien LE ROY, 0142499420, julien.leroy@aphp.fr
- Not yet recruiting
Pontoise Hospital
Pontoise, 95300
Djeneba Camara, +33130755059, djeneba.camara@ght-novo.fr
- Not yet recruiting
CHU Rennes - service MIR
Rennes, 35033
Nathanaël MANGEARD, 0299284321, Nathanael.MANGEARD@chu-rennes.fr
- Not yet recruiting
CHU Rennes - service Réa chir
Rennes, 35033
Morgan CHAUVIN, 0299288985, morgan.chauvin@churennes.fr
- Not yet recruiting
CH Saint-Nazaire
Saint-Nazaire, 44606
Jérôme HOFF, 0272278050, j.hoff@ch-saintnazaire.fr
- Not yet recruiting
La Réunion University Hospital
Saint-Pierre, La Réunion, BP350 97448
Nathalie Zemire, +33262359000, nathalie.zemire@chu-reunion.fr
- Not yet recruiting
Strasbourg University Hospital
Strasbourg, 67091
Julien Demiselle, +33369551079, julien.demiselle@chru-strasbourg.fr
- Not yet recruiting
CHU Tours
Tours, 37000
Isabelle ECAILLE, 0247479878, I.ECAILLE@chu-tours.fr
About this study
Official title: Impact of Infusion Line Change Frequency on Infectious Complications Related to Central Venous Catheters in the Intensive Care Unit ICU
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.
- Conditions
- Intensive Care (ICU), Central Venous Catheter Related Infections, Critical Care Nursing, Catheter-associated Bloodstream Infections (CLABSI), Nursing Workload
- Being tested
- 7-day Infusion set replacement, 4-day infusion set replacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
7-day Infusion set replacementProcedure or 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 replacementProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| 7-day infusion set replacement | Experimental | Infusion sets connected to the central venous catheter will be replaced every 7 days. Receives: Procedure: 7-day Infusion set replacement |
| 4-day infusion set replacement | Active comparator | Infusion sets connected to the central venous catheter will be replaced every 4 days. Receives: Procedure: 4-day infusion set replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate (%) of patients with with a central venous catheter-related infectious complication
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
Measured: From central venous catheter insertion until 48 hours after catheter removal during the ICU stay (censored at 90 days).
Secondary outcomes (8)
Central line-associated bloodstream infection (CLABSI)
Proportion of patients with central line-associated bloodstream infection
Measured: Day 90
Non-central line-associated bloodstream infection
Proportion of patients with non-central line-associated bloodstream infection
Measured: Day 90
Catheters with catheter colonization
Proportion of catheters with catheter colonization
Measured: 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
Length of time (in days) before the onset of central venous catheter-related infectious complications
Measured: Day 90
ICU length of stay
Length of ICU stay
Measured: Day 90
All-cause ICU mortality
Number of patients who die from any cause during their ICU stay
Measured: Day 90
Cumulative nursing time related to infusion set replacements
Total nursing time, measured in minutes, required to perform infusion set replacements, per 1000 catheter-days
Measured: 1000 days
Cost of materials required for infusion set replacements
Cost (euros) of materials required for infusion set replacements, per 1000 cathéter days
Measured: 1000 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start12 May 2026
- Primary completionMay 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care (ICU)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,830 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Carole Haubertin, Principal investigator, University Hospital, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07183592
- Sponsor's protocol ID
- 49RC24_0290
- Other IDs
- 2025-A01509-40
- Acronym
- TANDOORI
- Status last verified
- May 2026
- First submitted
- 12 Sep 2025
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided