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

Critically Ill Clinical Trial

— OCT-BIO-CVC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06216080
• Other study ID #: OCT-BIO-CVC
• Status: Recruiting
• Start date: May 1, 2023
• Est. completion date: March 31, 2024

Study information

• Verified date: January 2024
• Source: Centre Hospitalier William Morey - Chalon sur Saône
• Contact: Thomas Maldiney
• Phone: +33385910474
• Email: thomas.maldiney[@]ch-chalon71.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Central Venous Catheter Associated Bloodstream Infection
• Communicable Diseases
• Critical Illness
• Critically Ill
• Cross Infection
• Healthcare Associated Infection
• Infections
• Sepsis

Intervention

Other:
• 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

Locations

Country	Name	City	State
France	William Morey General Hospital (Chalon-sur-Saône)	Chalon sur Saône	Saône-et-Loire

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier William Morey - Chalon sur Saône	Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

References & Publications (2)

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

Outcome

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