Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06019897 |
| Other study ID # |
202300052 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 23, 2023 |
| Est. completion date |
January 2025 |
Study information
| Verified date |
August 2023 |
| Source |
University Hospital, Angers |
| Contact |
Maëva CAMPFORT, MD |
| Phone |
+33762755425 |
| Email |
maevacampfort[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The objective of this study is to assess the relationship between infusion system
colonization (ramps or multi-lumen devices) and the occurrence of CVC infection/colonization.
This study is a prospective observational research that does not modify usual patient care.
Its objective is to evaluate the relationship between infusion tubing colonization and the
occurrence of central venous catheter colonization.
The only additional intervention is swabbing the taps at each IV line ramp at systematic ramp
changes (done every 4 days) and at catheter removal. For the multi-lumen device, swabbing is
only performed upon catheter removal at the level of the one-way valves.
After catheter removal, a flush (1 mL of 0.9% NaCl) of the midline is performed and cultured
to assess for endoluminal colonization. The distal end of the CVC is sent for culture,
following the usual practice of the department to monitor catheter colonization and
infections.
The primary outcome measure is the proportion of colonized infusion systems based on the
culture of the CVC.
The secondary objectives are to describe factors associated with CVC infections, to determine
the incidence of colonization and infections in different locations of central venous
catheters, to analyze the bacterial ecology based on the type of infusion system used, and to
evaluate the ecological and economic impact of different devices (ramps vs. multi-lumen
devices).
The secondary outcome measures are as follows:
Proportion of colonized infusion systems based on the colonization status of the CVC and the
type of infusion system (ramps vs. multi-lumen devices) Proportion of colonized infusion
systems based on the infection status of the CVC and the type of infusion system (ramps vs.
multi-lumen devices) Duration of antibiotic treatment Weight of compounds used with each
infusion system over the duration of CVC placement (ramps vs. multi-lumen devices)
Calculation of material costs based on the infusion system used over the duration of CVC
placement (ramps vs. multi-lumen devices)
Description:
Central venous catheters (CVCs) are essential devices in the care of critically ill patients,
with approximately 63% of patients admitted to intensive care being exposed to them. While
they provide a safe access route for administering catecholamines or other substances
unsuitable for peripheral veins, they are also associated with complications, including
thrombotic and infectious events. CVC-related infections rank as the third most common
nosocomial infections in the intensive care unit, representing a major public health
challenge. According to the latest surveillance report on nosocomial infections in France,
the incidence density is 0.61 infections per 1,000 catheter-days and 0.49 catheter-related
bloodstream infections per 1,000 catheter-days. Approximately 10% of cultured catheters are
found to be positive, indicating colonization. These infections are associated with an
increased risk of mortality in the intensive care unit, estimated between 4% and 20%, as well
as a prolonged length of stay (5-20 days) and an additional cost of approximately €10,000 per
episode. Although catheter colonization has limited clinical impact, it remains a major
concern due to its role as a precursor to infection. CVC infection is defined by the presence
of microorganisms on the internal and/or external surface of the catheter, causing local
and/or systemic infection with or without bacteremia. There are several mechanisms of
infection, it is well accepted that infection begins with cutaneous colonization of the CVC,
which can then spread to the intravascular part of the catheter. Another source of infection
may be the colonization of infusion pathways leading to catheter colonization and infection
through the "endoluminal" route. Factors associated with CVC infection include the frequency
of line manipulations and the infused products. Therefore, it is recommended to minimize line
manipulations, adhere to strict aseptic measures when accessing infusion lines, and regularly
change (every 4 days) the infusion systems (ramps). Placing injection sites further away from
the insertion site reduces the risk of contamination. The first connector tubing is never
changed throughout the entire duration of CVC placement. However, there is limited data to
confirm the link between infusion pathway colonization (particularly ramps used in intensive
care) and catheter infection. The equipment used as infusion systems has evolved with the
introduction of new devices, such as multi-lumen devices. One of these devices consists of
five injection ports, each equipped with one-way valves, connected to a separate compartment
in the tubing system, allowing simultaneous intravenous administration of five different
active substances without mixing. This device is left in place for the entire duration of CVC
placement (compared to current systems that are changed every 4 days). The objective of this
study is to investigate whether there is a relationship between the colonization of infusion
systems (ramps and/or multi-lumen devices) and the occurrence of CVC infection/colonization,
and if this relationship varies depending on the type of device used (ramps vs. multi-lumen
devices).
All adult patients hospitalized in the ICU with a CVC in place for an expected duration >2
days will be proposed to participate, in absence of oral refusal, ramps of the tubing systems
will be swabed at each changes (scheduled every 4 days) and at catheter removal, in case of
multi-lumen devices (edelweiss system), swabbing will be only performed upon catheter removal
at the level of the one-way valves.
After catheter removal, a flush (1 mL of 0.9% NaCl) of the midline is performed and cultured
to assess for endoluminal colonization. The distal end of the CVC is sent for culture,
following the usual practice of the department to monitor catheter colonization and
infections.
Colonization of the tubing system (ramps or multi-lumen device) will be defined as a positive
culture of a swab, colonization and infection of the catheter will be defined using the CDC
definitions (positiive cultutre defined as ≥10p3 CFU/ml).
Rates of catheter colonization will be compared in colonized (positive culture of a swab) or
not colonized (no positiive swab culture) tubing systems. A sensibility analysis will be
conducted taking into acount only the ramps and catheter colonized with the same bacterial
strains.
