Description of Septic Thrombophlebitis on Central Venous Catheter and Midline

Not Applicable

Recruiting

• Conditions: Septic Thrombophlebitis
• Interventions: Diagnostic Test: Doppler ultrasound

• Registration Number: NCT05743738
• Lead Sponsor: Centre Hospitalier le Mans

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-02
• Study First Submitted: 2023-02-10
• Study First Submitted QC: 2023-02-22
• Study First Posted: 2023-02-24
• Study Start: 2023-05-31
• Last Update Submitted: 2023-06-14
• Last Update Posted: 2023-06-15
• Primary Completion: 2026-05-31
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• 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
• Patient capable of giving consent, or consent of the trusted person for patients not capable of giving consent at the time of inclusion
• Written consent signed by the participant and the investigator
• Person affiliated to social security

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Presence of thrombosis	Doppler ultrasound	Doppler ultrasound D8, D15, D30, D45, D60 and D90

Primary Outcome Measures

Name	Time	Method
Evaluation of duration of ultrasound signs of septic thrombophlebitis on central venous catheter and midline	Day 90	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

Trial Locations

Locations (2)

Centre Hospitalier Le Mans; 🇫🇷 Le Mans, France

CHU Angers; 🇫🇷 Angers, France