Impact of Infusion Line Change Frequency on Infectious Complications Related to Central Venous Catheters in the ICU - A Randomized Controlled Trial
NCT ID: NCT07183592
Last Updated: 2025-09-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
2830 participants
INTERVENTIONAL
2026-01-31
2028-04-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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7-day infusion set replacement
Infusion sets connected to the central venous catheter will be replaced every 7 days.
7-day Infusion set replacement
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
Infusion sets connected to the central venous catheter will be replaced every 4 days.
4-day infusion set replacement
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.
Interventions
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7-day Infusion set replacement
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
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
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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University Hospital, Angers
OTHER_GOV
Responsible Party
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Principal Investigators
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Carole Haubertin
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Angers
Locations
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La Réunion University Hospital
Saint-Pierre, La Réunion, France
Albi Hospital
Albi, , France
Angers University Hospital
Angers, , France
Belfort Hospital
Belfort, , France
Bourges Hospital
Bourges, , France
Caen University Hospital
Caen, , France
Chartres Hospital
Chartres, , France
Cholet Hospital
Cholet, , France
Colombes Hospital
Colombes, , France
Corbeil-Essonnes Hospital
Corbeil-Essonnes, , France
AP-HP - Henri Mondor Hospital
Créteil, , France
Dijon University Hospital
Dijon, , France
Garches Hospital
Garches, , France
Le Puy en Velay Hospital
Le Puy-en-Velay, , France
Macon Hospital
Mâcon, , France
Nantes University Hospital
Nantes, , France
Orleans University Hospital
Orléans, , France
AP-HP - Tenon Hospital
Paris, , France
Pontoise Hospital
Pontoise, , France
Strasbourg University Hospital
Strasbourg, , France
Countries
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Central Contacts
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Facility Contacts
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Carole Haubertin
Role: primary
Other Identifiers
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2025-A01509-40
Identifier Type: OTHER
Identifier Source: secondary_id
49RC24_0290
Identifier Type: -
Identifier Source: org_study_id
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