Clinical trial NCT06216080: Dynamic Full-Field Optical Coherence Tomography for Structural and Microbiological Characterization of Central Venous Catheter-deposited Biofilm in Critically Ill Patients
Official title: Dynamic Full-Field Optical Coherence Tomography for Structural and Microbiological Characterization of Central Venous Catheter-deposited Biofilm in Critically Ill Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthcare Associated Infection
Critically Ill
Central Venous Catheter Associated Bloodstream Infection
Lead sponsor: Centre Hospitalier William Morey - Chalon sur Saône
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Universitaire Dijon
First posted: 2024-01-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient over 18 years of age having declared their nonobjection and exposed to central venous catheter for at least two calendar days

Brief summary: 29.3% of bacteremias in intensive care units (ICU) are linked to vascular devices, with a significant proportion related to central venous catheters, and an influence on both morbility and mortality.

It is now accepted that microbiological biofilm plays a key role on both bacterial and fungal development on inner surface of vascular devices but there is yet a lack of clinical relevant data documenting a causal relation between biofilm formation and bacteremias.

We assume that a more precise characterization of central venous catheter-deposited biofilm could help us better understand invasive medical device-related healthcare infections in critically ill patients.


Eligibility criteria: Inclusion Criteria:

* Patient or relative informed of the study and having declared their nonobjection
* Patient over 18 years of age
* Patient exposed to central venous catheter for at least two calendar days

Exclusion Criteria:

* Patient unable to declare their nonobjection
* Patient whose central venous catheter collection is impossible
* Patient admitted in ICU with a central venous catheter already in place

Primary outcomes:
measure: D-FF-OCT-based biofilm structure type
timeFrame: At Day 0, within 24h following catheter removal
Secondary outcomes:
measure: D-FF-OCT-based biofilm thickness
timeFrame: At Day 0, within 24h following catheter removal
measure: D-FF-OCT-based dynamic signal distribution
timeFrame: At Day 0, within 24h following catheter removal
Other outcomes:
Locations:
city: Chalon sur Saône
country: France
facility: William Morey General Hospital (Chalon-sur-Saône)
state: Saône-et-Loire
Study officials:
affiliation: William Morey General Hospital (Chalon-sur-Saône)
name: Thomas Maldiney
role: PRINCIPAL_INVESTIGATOR
References:
citation: Perez-Granda MJ, Guembe M, Cruces R, Barrio JM, Bouza E. Assessment of central venous catheter colonization using surveillance culture of withdrawn connectors and insertion site skin. Crit Care. 2016 Feb 2;20:32. doi: 10.1186/s13054-016-1201-0.
citation: Silva Paes Leme AF, Ferreira AS, Alves FA, de Azevedo BM, de Bretas LP, Farias RE, Oliveira MG, Raposo NR. An effective and biocompatible antibiofilm coating for central venous catheter. Can J Microbiol. 2015 May;61(5):357-65. doi: 10.1139/cjm-2014-0783. Epub 2015 Mar 2.