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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-A01509-40 | Other Identifier | ANSM |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 7-day infusion set replacement | Experimental | Infusion sets connected to the central venous catheter will be replaced every 7 days. |
|
| 4-day infusion set replacement | Active Comparator | Infusion sets connected to the central venous catheter will be replaced every 4 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 7-day Infusion set replacement | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate (%) of patients with with a central venous catheter-related infectious complication | Infectious complications include:
| From central venous catheter insertion until 48 hours after catheter removal during the ICU stay (censored at 90 days). |
| Measure | Description | Time Frame |
|---|---|---|
| Central line-associated bloodstream infection (CLABSI) | Proportion of patients with central line-associated bloodstream infection | Day 90 |
| Non-central line-associated bloodstream infection | Proportion of patients with non-central line-associated bloodstream infection |
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Inclusion criteria
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:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carole Haubertin | Contact | +332 41 35 40 82 | Carole.Haubertin@chu-angers.fr | |
| Aurélie Hautefort | Contact | +332 41 35 58 99 | aurelie.hautefort@chu-angers.fr |
| Name | Affiliation | Role |
|---|---|---|
| Carole Haubertin | University Hospital, Angers | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| La Réunion University Hospital | Not yet recruiting | Saint-Pierre | La Réunion | BP350 97448 | France |
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| 4-day infusion set replacement | Procedure | 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. |
|
| Day 90 |
| Catheters with catheter colonization | Proportion of 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 | Length of time (in days) before the onset of central venous catheter-related infectious complications | Day 90 |
| ICU length of stay | Length of ICU stay | Day 90 |
| All-cause ICU mortality | Number of patients who die from any cause during their ICU stay | 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 | 1000 days |
| Cost of materials required for infusion set replacements | Cost (euros) of materials required for infusion set replacements, per 1000 cathéter days | 1000 days |
| Albi Hospital | Not yet recruiting | Albi | 81000 | France |
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| Angers University Hospital | Recruiting | Angers | 49933 | France |
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| Belfort Hospital | Not yet recruiting | Belfort | 90015 | France |
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| Bourges Hospital | Not yet recruiting | Bourges | 18000 | France |
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| Caen University Hospital | Not yet recruiting | Caen | 14033 | France |
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| CH Carcassonne | Not yet recruiting | Carcassonne | 11000 | France |
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| Chartres Hospital | Not yet recruiting | Chartres | France |
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| Cholet Hospital | Not yet recruiting | Cholet | 49300 | France |
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| Colombes Hospital | Not yet recruiting | Colombes | 92700 | France |
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| Corbeil-Essonnes Hospital | Not yet recruiting | Corbeil-Essonnes | 91106 | France |
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| AP-HP - Henri Mondor Hospital | Not yet recruiting | Créteil | 94000 | France |
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| Dijon University Hospital | Not yet recruiting | Dijon | 21079 | France |
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| Garches Hospital | Not yet recruiting | Garches | France |
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| CH Le Mans | Not yet recruiting | Le Mans | 72000 | France |
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| Le Puy en Velay Hospital | Not yet recruiting | Le Puy-en-Velay | 43000 | France |
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| Macon Hospital | Not yet recruiting | Mâcon | 71000 | France |
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| Nantes University Hospital | Not yet recruiting | Nantes | 44093 | France |
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| Orleans University Hospital | Not yet recruiting | Orléans | 45067 | France |
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| AP-HP - Tenon Hospital | Not yet recruiting | Paris | 75020 | France |
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| AP-HP - Saint Louis | Not yet recruiting | Paris | 75475 | France |
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| Pontoise Hospital | Not yet recruiting | Pontoise | 95300 | France |
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| CHU Rennes - service MIR | Not yet recruiting | Rennes | 35033 | France |
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| CHU Rennes - service Réa chir | Not yet recruiting | Rennes | 35033 | France |
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| CH Saint-Nazaire | Not yet recruiting | Saint-Nazaire | 44606 | France |
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| Strasbourg University Hospital | Not yet recruiting | Strasbourg | 67091 | France |
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| CHU Tours | Not yet recruiting | Tours | 37000 | France |
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