Structural and Microbiological Characterization of Arterial Catheter Biofilm in ICU's Patients Using Optical Coherence Tomography

NCT06838598 | Recruiting

• 1 other identifier: OCT-BIO-KTA
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

29.3% of bacteremias in intensive care units (ICU) are linked to vascular devices, including 7.7% to arterial catheters, with an influence on both morbility and mortality. It is now accepted that biofilm as a role on bacterial 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. The investigators assume that a better structural and microbiological characterization of arterial catheter biofilm in ICU patients could help preventing bacteremias or have a more specific treatment when it appears.

Conditions

Biofilms; Arterial Catheterization, Peripheral; Bacteremia; Tomography, Optical Coherence

Outcome Measures

Primary Outcomes (1)

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

  Provide a better understanding of the relation between structural and microbiological characterization of artherial catheter biofilm in ICU patients using D-FF-OCT

  Outcome measure is assessed 2 days following catheter removal

Secondary Outcomes (3)

• Bacterial or fungal indentification

  Outcome measure is assessed 2 days following catheter removal

• Biofilm thickness, measured with D-FF-OCT

  Outcome measure is assessed 2 days following catheter removal

• Biofilm dynamic signal distribution, measured with D-FF-OCT

  Outcome measure is assessed 2 days following catheter removal

Study Arms (1)

OCT-BIO-KTA cohort

Critically ill patient \> 18 years of age with artherial catheter for \>2 calendar days in ICU

Other: OCT-BIO-KTA cohort

Interventions

OCT-BIO-KTA cohort OTHER

Dynamic full-field optical coherence tomography (D-FF-OCT) analysis of arterial catheter sections before microbiological analysis of catheter biofilm

OCT-BIO-KTA 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 with artherial catheter more than 2 calendar days

You may qualify if:

• Patient or relative informed of the study and having declared their non-objection
• Patient over 18 years old
• Patient hospitalized in ICU with an arterial catheter

You may not qualify if:

• Patient unable to express consent
• Patient whose collection of the arterial catheter is impossible or for whom storage at 4°C is impossible
• Patient with arterial catheter removed outside the usual procedure of the ICU
• Patient admitted in ICU with an arterial catheter already in place

Sponsors & Collaborators

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

Study Sites (2)

CHU Dijon Bourgogne

Dijon, Bourgogne-Franche-Comté, 21000, France

RECRUITING

CH Macon

Mâcon, Bourgogne-Franche-Comté, 71000, France

RECRUITING

MeSH Terms

Conditions

Bacteremia

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Florian PERRAUD

CONTACT

06 78 58 85 19; florian.perraud@ch-chalon.fr

Thomas MALDINEY

CONTACT

thomas.maldiney@ch-chalon.fr

Study Design

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

Study Record Dates

• First Submitted: August 21, 2024
• First Posted: February 20, 2025
• Study Start: June 3, 2024
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

FR (2)