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NCT Number: NCT06838598

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

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.

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Key information

Conditions

Biofilms Arterial Catheterization, Peripheral Bacteremia Bacterial Infections Bacterial Infections and Mycoses Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome Tomography, Optical Coherence

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Dijon Bourgogne, Dijon, Bourgogne-Franche-Comté, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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

Primary outcomes

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

    Time frame: Outcome measure is assessed 2 days following catheter removal

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

Secondary outcomes

  1. Bacterial or fungal indentification

    Time frame: Outcome measure is assessed 2 days following catheter removal

    Identification and enumeration of species - whether bacterial or fungal - by mass spectrometry from culture in agar medium of biofilm samples

  2. Biofilm thickness, measured with D-FF-OCT

    Time frame: Outcome measure is assessed 2 days following catheter removal

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

  3. Biofilm dynamic signal distribution, measured with D-FF-OCT

    Time frame: Outcome measure is assessed 2 days following catheter removal

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

Study contacts

Contact information is provided by the study sponsor or research team.

Florian PERRAUD

CONTACT

[email protected]

06 78 58 85 19

Thomas MALDINEY

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Centre Hospitalier William Morey - Chalon sur Saône

Other

Collaborators

  • Centre Hospitalier Macon
  • Centre Hospitalier Universitaire Dijon

Registry information

Acronym: OCT-BIO-KTA

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Feb 20, 2025
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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