Impact of Infusion Line Change Frequency on Infectious Complications Related to Central Venous Catheters in the ICU - A Randomized Controlled Trial
TANDOORI
2 other identifiers
interventional
2,830
1 country
20
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2026
Typical duration for not_applicable
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 12, 2025
CompletedFirst Posted
Study publicly available on registry
September 19, 2025
CompletedStudy Start
First participant enrolled
January 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2028
September 29, 2025
September 1, 2025
2.2 years
September 12, 2025
September 23, 2025
Conditions
Outcome Measures
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
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)
Day 90
Non-central line-associated bloodstream infection
Day 90
Catheters with catheter colonization
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
Day 90
ICU length of stay
Day 90
- +3 more secondary outcomes
Study Arms (2)
7-day infusion set replacement
EXPERIMENTALInfusion sets connected to the central venous catheter will be replaced every 7 days.
4-day infusion set replacement
ACTIVE COMPARATORInfusion sets connected to the central venous catheter will be replaced every 4 days.
Interventions
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 (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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
La Réunion University Hospital
Saint-Pierre, La Réunion, BP350 97448, France
Albi Hospital
Albi, 81000, France
Angers University Hospital
Angers, 49933, France
Belfort Hospital
Belfort, 90015, France
Bourges Hospital
Bourges, 18000, France
Caen University Hospital
Caen, 14033, France
Chartres Hospital
Chartres, France
Cholet Hospital
Cholet, 49300, France
Colombes Hospital
Colombes, 92700, France
Corbeil-Essonnes Hospital
Corbeil-Essonnes, 91106, France
AP-HP - Henri Mondor Hospital
Créteil, 94000, France
Dijon University Hospital
Dijon, 21079, France
Garches Hospital
Garches, France
Le Puy en Velay Hospital
Le Puy-en-Velay, 43000, France
Macon Hospital
Mâcon, 71000, France
Nantes University Hospital
Nantes, 44093, France
Orleans University Hospital
Orléans, 45067, France
AP-HP - Tenon Hospital
Paris, 75020, France
Pontoise Hospital
Pontoise, 95300, France
Strasbourg University Hospital
Strasbourg, 67091, France
Study Officials
- PRINCIPAL INVESTIGATOR
Carole Haubertin
University Hospital, Angers
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2025
First Posted
September 19, 2025
Study Start
January 1, 2026
Primary Completion (Estimated)
April 1, 2028
Study Completion (Estimated)
April 1, 2028
Last Updated
September 29, 2025
Record last verified: 2025-09