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

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.

Study Overview

• Status: Recruiting
• Conditions: Critically Ill; Central Venous Catheter Associated Bloodstream Infection; Healthcare Associated Infection
• Intervention / Treatment: Other: D-FF-OCT analysis of CVC

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Thomas Maldiney; Phone Number: +33385910474; Email: thomas.maldiney@ch-chalon71.fr
• Study Contact Backup: Name: Claudine DESBROSSES; Email: Claudine.Desbrosses@ch-chalon71.fr

Study Locations

• France
  • Saône-et-Loire
    • Chalon sur Saône, Saône-et-Loire, France, 71100
      • Recruiting
      • William Morey General Hospital (Chalon-sur-Saône)
      • Contact: Thomas Maldiney; Phone Number: +33 3 85 91 01 11; Email: thomas.maldiney@ch-chalon71.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Dynamic full-field optical coherence tomography analysis of central venous catheter sections to better apprehend strucural characterization of central venous catheter-deposited biofilm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
D-FF-OCT-based biofilm thickness	Biofilm thickness, measured with D-FF-OCT	At Day 0, within 24h following catheter removal
D-FF-OCT-based dynamic signal distribution	Biofilm dynamic signal distribution, measured with D-FF-OCT	At Day 0, within 24h following catheter removal

Collaborators and Investigators

• Sponsor: Centre Hospitalier William Morey - Chalon sur Saône
• Collaborators: Centre Hospitalier Universitaire Dijon
• Investigators: Principal Investigator: Thomas Maldiney, William Morey General Hospital (Chalon-sur-Saône)

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Estimated): January 31, 2024
• Study Completion (Estimated): March 31, 2024

Study Registration Dates

• First Submitted: January 1, 2024
• First Submitted That Met QC Criteria: January 11, 2024
• First Posted (Actual): January 22, 2024

Study Record Updates

• Last Update Posted (Actual): January 22, 2024
• Last Update Submitted That Met QC Criteria: January 11, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Systemic Inflammatory Response Syndrome; Inflammation; Disease Attributes; Iatrogenic Disease; Sepsis; Infections; Communicable Diseases; Critical Illness; Cross Infection
• Other Study ID Numbers: OCT-BIO-CVC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No