Critically Ill Clinical Trial
— OCT-BIO-CVCOfficial title:
Dynamic Full-Field Optical Coherence Tomography for Structural and Microbiological Characterization of Central Venous Catheter-deposited Biofilm in Critically Ill Patients
NCT number | NCT06216080 |
Other study ID # | OCT-BIO-CVC |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | May 1, 2023 |
Est. completion date | March 31, 2024 |
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | March 31, 2024 |
Est. primary completion date | January 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | William Morey General Hospital (Chalon-sur-Saône) | Chalon sur Saône | Saône-et-Loire |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier William Morey - Chalon sur Saône | Centre Hospitalier Universitaire Dijon |
France,
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M, Cruces R, Barrio JM, Bouza E. Assessment of central venous catheter colonization using surveillance culture of withdrawn connectors and insertion site skin.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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | D-FF-OCT-based biofilm thickness | Biofilm thickness, measured with D-FF-OCT | At Day 0, within 24h following catheter removal | |
Secondary | D-FF-OCT-based dynamic signal distribution | Biofilm dynamic signal distribution, measured with D-FF-OCT | At Day 0, within 24h following catheter removal |
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