Dynamic Full-Field Optical Coherence Tomography for Structural and Microbiological Characterization of Central Venous Catheter-deposited Biofilm in Critically Ill Patients

NCT06216080 | Completed

• 1 other identifier: OCT-BIO-CVC
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthcare Associated Infection; Critically Ill; Central Venous Catheter Associated Bloodstream Infection

Outcome Measures

Primary Outcomes (1)

• D-FF-OCT-based biofilm structure type

  Biofilm structure type (ribbon-shaped or mushroom-shaped), measured with D-FF-OCT

  At Day 0, within 24h following catheter removal

Secondary Outcomes (2)

• D-FF-OCT-based biofilm thickness

  At Day 0, within 24h following catheter removal

• D-FF-OCT-based dynamic signal distribution

  At Day 0, within 24h following catheter removal

Study Arms (1)

OCT-BIO-CVC cohort

Adult critically ill patients (\> 18 years of age) exposed to central venous catheter for at least two calendar days

Other: D-FF-OCT analysis of CVC

Interventions

D-FF-OCT analysis of CVC OTHER

Dynamic full-field optical coherence tomography analysis of central venous catheter sections to better apprehend strucural characterization of central venous catheter-deposited biofilm

OCT-BIO-CVC cohort

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier William Morey - Chalon sur Saône: lead
• Centre Hospitalier Universitaire Dijon: collaborator

Study Sites (1)

William Morey General Hospital (Chalon-sur-Saône)

Chalon-sur-Saône, Saône-et-Loire, 71100, France

Location

Related Publications (2)

• 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.

  PMID: 26838274 BACKGROUND

• 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.

  PMID: 25826042 BACKGROUND

MeSH Terms

Conditions

Cross Infection; Critical Illness

Condition Hierarchy (Ancestors)

Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Thomas Maldiney

  William Morey General Hospital (Chalon-sur-Saône)

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 1, 2024
• First Posted: January 22, 2024
• Study Start: May 1, 2023
• Primary Completion: December 30, 2024
• Study Completion: February 10, 2025
• Last Updated: February 18, 2025

Record last verified: 2024-01

Locations

FR (1)