Description of Septic Thrombophlebitis on Central Venous Catheter and Midline (THROMBOSEP)

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.

Study Overview

• Status: Recruiting
• Conditions: Septic Thrombophlebitis
• Intervention / Treatment: Diagnostic test: Doppler ultrasound

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christelle JADEAU; Phone Number: +33244710781; Email: cjadeau@ch-lemans.fr

Study Locations

• France
  • Angers, France, 49000
    • Not yet recruiting
    • CHU Angers
    • Contact: Diama NDIAYE, MD; Phone Number: 02 41 35 33 05; Email: Diama.Ndiaye@chu-angers.fr
    • Principal Investigator: Diama NDIAYE, MD
  • Le Mans, France, 72 000
    • Recruiting
    • Centre Hospitalier Le Mans
    • Contact: Christelle Jadeau, PD; Phone Number: 02 44 71 07 81; Email: cjadeau@ch-lemans.fr
    • Contact: Lucia Grandiere-Perez, MD; Phone Number: 0 (33) 2 43 43 43 43; Email: lperez@ch-lemans.fr
    • Principal Investigator: Lucia Grandiere-Perez, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Presence of thrombosis; Doppler ultrasound D8, D15, D30, D45, D60 and D90	Diagnostic test: Doppler ultrasound; Control venous Doppler ultrasound
No Intervention: Absence of thrombosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier le Mans

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2023
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: February 10, 2023
• First Submitted That Met QC Criteria: February 22, 2023
• First Posted (Actual): February 24, 2023

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: June 14, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Doppler ultrasound; septic thrombophlebitis
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Vasculitis; Venous Thrombosis; Thrombosis; Peripheral Vascular Diseases; Phlebitis; Thrombophlebitis
• Other Study ID Numbers: CHM-2020/S10/14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No