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

NCT06019897 | Unknown

• 1 other identifier: 202300052
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

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 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)

Conditions

Catheter-Related Infections; Catheter Complications; Catheter Infection; Catheter-related Bloodstream Infection; Catheter Related Complication

Keywords

Catheter related infection; catheter colonization

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Number of days without antibiotics at Day 42 (in the ICU)

  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

• Incidence of central venous catheter infection according to the tubing colonization

  up to catheter removal or up to 6 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients admitted in a surgical intensive care unit and requiring a central venous catheter for drug administration

You may qualify if:

• 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)

You may not qualify if:

• Patients \< 18 years old
• Patients under legal protection
• Patients who refuse the use of their data

Sponsors & Collaborators

• University Hospital, Angers: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

We will swab 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. All these samples will be cultured on agar plates for microbial detection, quantification and identification.

MeSH Terms

Conditions

Catheter-Related Infections

Condition Hierarchy (Ancestors)

Infections

Study Officials

• sigismond lasocki, MD, PhD

  CHU Angers, 49033 Angers Cedex 01, France

  STUDY DIRECTOR

Central Study Contacts

Maëva CAMPFORT, MD

CONTACT

+33762755425; maevacampfort@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2023
• First Posted: August 31, 2023
• Study Start: October 23, 2023
• Primary Completion: November 1, 2024
• Study Completion: January 1, 2025
• Last Updated: October 6, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share