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

NCT ID: NCT06216080

Last Updated: 2025-02-18

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

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-01

Study Completion Date

2025-02-10

Brief Summary

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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.

Detailed Description

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Conditions

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Healthcare Associated Infection Critically Ill Central Venous Catheter Associated Bloodstream Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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OCT-BIO-CVC cohort

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

D-FF-OCT analysis of CVC

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
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 William Morey - Chalon sur Saône

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas Maldiney

Role: PRINCIPAL_INVESTIGATOR

William Morey General Hospital (Chalon-sur-Saône)

Locations

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William Morey General Hospital (Chalon-sur-Saône)

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

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 26838274 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25826042 (View on PubMed)

Other Identifiers

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OCT-BIO-CVC

Identifier Type: -

Identifier Source: org_study_id

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