Catheter-Related InfectionsCRICNCT06019897
Impact of Tubing Colonization on the Incidence of Central Venous Catheter Infection
An observational study of Catheter-Related Infections and Catheter Complications, run by University Hospital, Angers.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Catheter-Related Infections, Catheter Complications, Catheter Infection
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 23 Oct 2023to Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients admitted in a surgical intensive care unit and requiring a central venous catheter for drug administration
Who may be able to join
- 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)
Who cannot join
- Patients < 18 years old
- Patients under legal protection
- Patients who refuse the use of their data
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Impact of Tubing Colonization on the Incidence of Central Venous Catheter Infection. Observational Study CRIC (Colonisation Des Rampes et Infection de Cathéters)
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.
Read more
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)
Read the 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, 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.
- Conditions
- Catheter-Related Infections, Catheter Complications, Catheter Infection, Catheter-related Bloodstream Infection, Catheter Related Complication
- Keywords
- Catheter related infection, catheter colonization
- Medical subject headings
- Catheter-Related Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of central venous catheter colonization according to the status colonized or not of the tubing
catheter colonization is defined as a positive culture of the catheter tips ≥ 10p3 CFU/ml and compare the rates in catheter with or without a positive culture of tubiging systems
Measured: up to Catheter removal or up to 6 weeks
Secondary outcomes (4)
Number of days without antibiotics at Day 42 (in the ICU)
number of days without any antibiotic prescribed at day 42, while in the ICU. All the days outside the ICU will be considered as without antibiotics.
Measured: up to Catheter removal or up to 6 weeks
Incidence of colonization and infection of central venous catheter according to their site
we will use the CDC definition for catheter infection (with a positive culture of the catheter tips≥10p3 CFU/ml), and compare the rates in catheter with or without a positive culture of tubiging systems
Measured: 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
we will use the CDC definition for catheter infection (with a positive culture of the catheter tips≥10p3 CFU/ml), and compare the rates in catheter with ramps or with multilumen device
Measured: up to catheter removal or up to 6 weeks
Incidence of central venous catheter infection according to the tubing colonization
we will use the CDC definition for catheter infection we will use the CDC definitions for catheter infection (with a positive culture of the catheter tips≥10p3 CFU/ml), and compare the rates in catheter with or without a positive culture of tubiging systems
Measured: up to catheter removal or up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2023
- Study start23 Oct 2023 (estimated)
- Primary completionNov 2024 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Catheter-Related InfectionsStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- sigismond lasocki, MD, PhD, Study director, CHU Angers, 49033 Angers Cedex 01, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06019897
- Sponsor's protocol ID
- 202300052
- Acronym
- CRIC
- Status last verified
- Aug 2023
- First submitted
- 25 May 2023
- Last updated
- 6 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no plan
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Tubing Colonization on the Incidence of Central Venous Catheter Infection. Observational Study CRIC (Colonisation Des Rampes et Infection de Cathéters)
- ClinicalTrials.gov ID
- NCT06019897
- Acronym / sponsor ID
- CRIC / 202300052
- Conditions
- Catheter-Related Infections, Catheter Complications, Catheter Infection, Catheter-related Bloodstream Infection, Catheter Related Complication
- Keywords
- Catheter related infection, catheter colonization
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 23 Oct 2023 (estimated)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 31 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
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, 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients admitted in a surgical intensive care unit and requiring a central venous catheter for drug administration
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- Patients < 18 years old
- Patients under legal protection
- Patients who refuse the use of their data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of central venous catheter colonization according to the status colonized or not of the tubing
Time frame: up to Catheter removal or up to 6 weeks
catheter colonization is defined as a positive culture of the catheter tips ≥ 10p3 CFU/ml and compare the rates in catheter with or without a positive culture of tubiging systems
4 secondary outcomes
Number of days without antibiotics at Day 42 (in the ICU)
Time frame: up to Catheter removal or up to 6 weeks
Incidence of colonization and infection of central venous catheter according to their site
Time frame: 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
Time frame: up to catheter removal or up to 6 weeks
Incidence of central venous catheter infection according to the tubing colonization
Time frame: up to catheter removal or up to 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2023.
- Individual participant dataSharing planned: No. no plan
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
sigismond lasocki, MD, PhD study director
CHU Angers, 49033 Angers Cedex 01, France
Questions about this trial
What is this clinical trial studying?
An observational study of Catheter-Related Infections and Catheter Complications, run by University Hospital, Angers.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maëva CAMPFORT, MD (+33762755425, maevacampfort@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of central venous catheter colonization according to the status colonized or not of the tubing (time frame: up to Catheter removal or up to 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2023.