Description of Septic Thrombophlebitis on Central Venous Catheter and Midline

NCT05743738 | Recruiting

• 1 other identifier: CHM-2020/S10/14
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief Summary

Central venous catheters improve the tolerability and feasibility of patient care in the hospital setting by allowing the administration of hyper-osmotic, vesicant and venotoxic fluids. Despite these advantages, the long-term presence of central venous catheters is associated with thrombotic and infectious risks , including catheter-related bacteremia, which can be complicated by septic thrombophlebitis and endocarditis that can lead to death. Septic thrombophlebitis is a complication of venous catheter infections, which increases the morbidity. It is defined by the presence of a thrombosis in the vein where the venous catheter is located, associated with a bacteremia. A distinction is made between superficial and deep thrombophlebitis. The frequency of septic thrombophlebitis of venous catheters is variable and poorly described in the literature. When the diagnosis of septic thrombophlebitis is made, it is recommended to extend the duration of antibiotic therapy, to remove the infected catheter and to prescribe anticoagulant treatment. However, there is no recommendation on the duration of anticoagulation for septic thrombophlebitis, whether it is deep or superficial. Investigator proposes a prospective and descriptive interventional study to describe the ultrasound evolution of thrombus in patients with septic thrombophlebitis on central venous catheter and midline.

Conditions

Septic Thrombophlebitis

Keywords

septic thrombophlebitis; Doppler ultrasound

Outcome Measures

Primary Outcomes (1)

• Evaluation of duration of ultrasound signs of septic thrombophlebitis on central venous catheter and midline

  the duration is measured by time from the day of diagnosis of septic thrombophlebitis to the day of disappearance of signs of thrombophlebitis on Doppler ultrasound

  Day 90

Study Arms (2)

Presence of thrombosis

OTHER

Doppler ultrasound D8, D15, D30, D45, D60 and D90

Diagnostic Test: Doppler ultrasound

Absence of thrombosis

NO INTERVENTION

Interventions

Doppler ultrasound DIAGNOSTIC_TEST

Control venous Doppler ultrasound

Presence of thrombosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patient hospitalised at the CHM or CHUA, with a central venous device (Implantable chamber, central venous jugular, femoral, subclavian, PICCline, dialysis catheter) or a Midline and having catheter-related bacteremia
• Catheter-related bacteremia according to the following definition (ePOPI): Positive blood cultures within 48 hours of a suspected catheter infection (or its removal) With one of the following criteria: - Before catheter removal: differential time of positivity of central/peripheral blood cultures ≥ 2 hours
• After catheter removal: positive catheter culture ≥ 103 CFU/ml, with the same organism.
• Patient transportable for ultrasound or ultrasound can be performed in the patient's bed
• Written consent signed by the participant and the investigator
• Person affiliated to social security

You may not qualify if:

• Patient with a life expectancy of less than one month
• Contraindication to anticoagulation
• Patient already on curative anticoagulant therapy for any indication
• Minor or adult patient under guardianship or protected or deprived of liberty
• Pregnant, nursing or parturient woman

Sponsors & Collaborators

• Centre Hospitalier le Mans: lead

Study Sites (2)

CHU Angers

Angers, 49000, France

NOT YET RECRUITING

Centre Hospitalier Le Mans

Le Mans, 72 000, France

RECRUITING

MeSH Terms

Interventions

Ultrasonography, Doppler

Intervention Hierarchy (Ancestors)

Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Christelle JADEAU

CONTACT

+33244710781; cjadeau@ch-lemans.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2023
• First Posted: February 24, 2023
• Study Start: May 31, 2023
• Primary Completion: May 31, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: June 15, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)