Changing infusion lines every 4 days versus every 7 days to prevent catheter infections in the ICU

Impact of Infusion Line Change Frequency on Infectious Complications Related to Central Venous Catheters in the Intensive Care Unit ICU

This will test whether changing infusion lines every 7 days instead of every 4 days affects infection risk in adult ICU patients with central venous catheters.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 2830 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Hospital, Angers (other gov)
• Locations: 27 sites (Saint-Pierre, La Réunion and 26 other locations)
• Trial ID: NCT07183592 on ClinicalTrials.gov

What this trial studies

This randomized controlled trial enrolls adult ICU patients who have a central venous catheter placed by venipuncture within the past 72 hours and are expected to need it for at least 7 days. Participants are assigned to have infusion sets changed either every 4 days or every 7 days and are followed for catheter-related infections and bloodstream infection rates. The protocol keeps standard insertion and handling precautions the same for both arms and records nursing workload and device-related complications. Safety monitoring will capture any suspected catheter-related infections that require device removal or additional treatment.

Who should consider this trial

Good fit: Adult ICU patients with a central venous catheter inserted by venipuncture within 72 hours who are expected to need the catheter for at least 7 days and who can give consent or have proxy/third-party consent.

Not a fit: Patients with a documented or suspected bloodstream infection at inclusion, catheters in place for more than 72 hours, catheters inserted by guidewire exchange, known allergy to catheter material, confirmed deep vein thrombosis at insertion, or those not expected to require the catheter for ≥7 days are unlikely to benefit.

Why it matters

Potential benefit: If successful, this could allow safely extending infusion-set replacement intervals, lowering nurse workload and healthcare costs without increasing infections.

How similar studies have performed: Previous evidence is limited and mixed: international guideline recommendations commonly target 4-day changes while the CDC allows up to 7 days, and randomized trials directly comparing 4- versus 7-day replacement are scarce.

Eligibility criteria

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

Where this trial is running

Saint-Pierre, La Réunion and 26 other locations

• La Réunion University Hospital — Saint-Pierre, La Réunion, France (NOT_YET_RECRUITING)
• Albi Hospital — Albi, France (NOT_YET_RECRUITING)
• Angers University Hospital — Angers, France (RECRUITING)
• Belfort Hospital — Belfort, France (NOT_YET_RECRUITING)
• Bourges Hospital — Bourges, France (NOT_YET_RECRUITING)
• Caen University Hospital — Caen, France (NOT_YET_RECRUITING)
• CH Carcassonne — Carcassonne, France (NOT_YET_RECRUITING)
• Chartres Hospital — Chartres, France (NOT_YET_RECRUITING)
• Cholet Hospital — Cholet, France (NOT_YET_RECRUITING)
• Colombes Hospital — Colombes, France (NOT_YET_RECRUITING)
• Corbeil-Essonnes Hospital — Corbeil-Essonnes, France (NOT_YET_RECRUITING)
• AP-HP - Henri Mondor Hospital — Créteil, France (NOT_YET_RECRUITING)
• Dijon University Hospital — Dijon, France (NOT_YET_RECRUITING)
• Garches Hospital — Garches, France (NOT_YET_RECRUITING)
• CH Le Mans — Le Mans, France (NOT_YET_RECRUITING)
• Le Puy en Velay Hospital — Le Puy-en-Velay, France (NOT_YET_RECRUITING)
• Macon Hospital — Mâcon, France (NOT_YET_RECRUITING)
• Nantes University Hospital — Nantes, France (NOT_YET_RECRUITING)
• Orleans University Hospital — Orléans, France (NOT_YET_RECRUITING)
• AP-HP - Tenon Hospital — Paris, France (NOT_YET_RECRUITING)
• AP-HP - Saint Louis — Paris, France (NOT_YET_RECRUITING)
• Pontoise Hospital — Pontoise, France (NOT_YET_RECRUITING)
• CHU Rennes - service MIR — Rennes, France (NOT_YET_RECRUITING)
• CHU Rennes - service Réa chir — Rennes, France (NOT_YET_RECRUITING)
• CH Saint-Nazaire — Saint-Nazaire, France (NOT_YET_RECRUITING)
• Strasbourg University Hospital — Strasbourg, France (NOT_YET_RECRUITING)
• CHU Tours — Tours, France (NOT_YET_RECRUITING)

Study contacts

• Principal investigator: Carole Haubertin — University Hospital, Angers
• Study coordinator: Carole Haubertin

Conditions: Intensive Care, Central Venous Catheter Related Infections, Critical Care Nursing, Catheter-associated Bloodstream Infections, Nursing Workload