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

NCT ID: NCT06838598

Last Updated: 2025-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-03

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Biofilms Arterial Catheterization, Peripheral Bacteremia Tomography, Optical Coherence

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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OCT-BIO-KTA cohort

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

OCT-BIO-KTA cohort

Intervention Type OTHER

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

Interventions

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OCT-BIO-KTA cohort

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role collaborator

Centre Hospitalier Macon

OTHER

Sponsor Role collaborator

Centre Hospitalier William Morey - Chalon sur Saône

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Dijon Bourgogne

Dijon, Bourgogne-Franche-Comté, France

Site Status RECRUITING

CH Macon

Mâcon, Bourgogne-Franche-Comté, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Florian PERRAUD

Role: CONTACT

06 78 58 85 19

Thomas MALDINEY

Role: CONTACT

Facility Contacts

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QUENOT Jean Pierre, MD-PhD

Role: primary

MAILLET Thibault, MD

Role: primary

Other Identifiers

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OCT-BIO-KTA

Identifier Type: -

Identifier Source: org_study_id

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