CRIC: Impact of Tubing Colonization on the Incidence of Central Venous Catheter Infection

Sponsor

University Hospital, Angers (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06019897

Collaborator

(none)

200

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief 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 alter patient management. Its objective is to evaluate the relationship between infusion tubing colonization and the occurrence of central venous catheter infections.

The only additional intervention is swabbing the taps at each ramp change (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 infection status of the CVC.

The secondary objectives are to describe factors associated with CVC infections, determine the incidence of colonization and infections in different locations of central venous catheters, analyze the bacterial ecology based on the type of infusion system used, and 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)

Condition or Disease	Intervention/Treatment	Phase
Catheter-Related Infections Catheter Complications Catheter Infection Catheter-related Bloodstream Infection Catheter Related Complication

Detailed 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, posing 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. Traditionally, it is believed that infection begins with cutaneous colonization of the CVC, which can then spread to the intravascular part of the catheter. Another cause of infection is 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 not changed throughout the entire duration of CVC placement. However, there is limited recent data confirming 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).

Study Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Impact of Tubing Colonization on the Incidence of Central Venous Catheter Infection. Observational Study CRIC (Colonisation Des Rampes et Infection de Cathéters)

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Nov 1, 2024

Anticipated Study Completion Date :

Jan 1, 2025

Outcome Measures

Primary Outcome Measures

Incidence of central venous catheter infection according to the status colonized or not of the tubing [up to Catheter removal or up to 6 weeks]

Secondary Outcome Measures

Number of days with antibiotics [up to Catheter removal or up to 6 weeks]
Incidence of colonization and infection of central venous catheter according to their site [up to Catheter removal]
Incidence of central venous catheter colonization according to the colonization of tubing and to the use or not of a multi lumen device [up to catheter removal or up to 6 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Adults > 18 years old
Admitted in Surgical Intensive Care unit
Requiring a central venous catheter for more than 48h for drug administration (central venous catheter for renal replacement therapy are excluded)