Clinical Trials Logo

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 200
Est. completion date January 2025
Est. primary completion date November 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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) Exclusion Criteria: - Patients < 18 years old - Patients under legal protection - Patients who refuse the use of their data

Study Design


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Angers

Outcome

Type Measure Description Time frame Safety issue
Primary 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 up to Catheter removal or up to 6 weeks
Secondary 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. up to Catheter removal or up to 6 weeks
Secondary 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 up to Catheter removal
Secondary 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 up to catheter removal or up to 6 weeks
Secondary 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 up to catheter removal or up to 6 weeks
See also
  Status Clinical Trial Phase
Terminated NCT04787926 - DuraLock-C Catheter Lock Solution
Active, not recruiting NCT02515201 - Heparin Versus Taurolidine to Bloodstream Infection Prevention Related in Central Venous Catheter in Children Phase 4
Recruiting NCT04140916 - Comparison of Two Peripheral Inserted Intravenous Catheters N/A
Completed NCT02970409 - Heparin Versus Saline in Peripheral Venous Catheter N/A
Completed NCT03101371 - Reducing Urinary Tract Infection Rates Using a Controlled Aseptic Protocol for Catheter Insertion Phase 2
Completed NCT04821193 - Comparison of the Effects of 5%NaHCO3, 2%CHG and 70%Alcohol in the Prevention of Infections Related to Catheter N/A
Completed NCT04155723 - Impact of a Task Delegation to ICU Nurses for Midlines' Placement
Completed NCT02577718 - Safety and Effectiveness of Novel Nitroglycerin Based Catheter Lock Solution Phase 1/Phase 2
Completed NCT02279121 - ATAPAC Study (TauroLock Activity in Adult Cancer Patients) N/A
Completed NCT00965198 - Comparison of Infection Rates Among Patients Using Two Catheter Access Devices N/A
Recruiting NCT05741866 - Novel Antimicrobial Dressing in Peripheral Intravenous Catheters (PIVCs) N/A
Recruiting NCT04825314 - Noble Meta Alloy Coated Catheters in Patients With Long Term Catheterization N/A
Active, not recruiting NCT03945045 - A Study of the IJV or the SCV Approach for Ultrasound-guided Implantation of TIVAD N/A
Active, not recruiting NCT01592032 - Concentration of Antimicrobials in Catheter-lock Solutions Phase 4
Terminated NCT04906512 - Comparing CHG I.V. Securement Dressing With Transparent Dressing for Evaluation of Antimicrobial Efficacy N/A
Withdrawn NCT02899780 - Treatment of Infected Dialysis Catheters With Fiber Optic Ultraviolet Light N/A
Recruiting NCT05995080 - The Effectiveness of Chlorhexidine Gluconate on Prevention of Catheter-Related Bloodstream Infections N/A
Completed NCT04794231 - Comparison of Chlorhexidine Impregnated Dressing and Standard Dressing N/A
Terminated NCT03447639 - Betadine Bladder Irrigations vs. Standard of Care Prior to Indwelling Catheter Removal Phase 4
Completed NCT03950921 - Pilot Testing a Patient Safety Display in the Hospital Setting N/A