Description of Septic Thrombophlebitis on Central Venous Catheter and Midline

Last updated: June 14, 2023
Sponsor: Centre Hospitalier le Mans
Overall Status: Active - Recruiting

Phase

N/A

Condition

Venous Thrombosis

Deep Vein Thrombosis

Treatment

Doppler ultrasound

Clinical Study ID

NCT05743738
CHM-2020/S10/14
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult patient hospitalised at the CHM or CHUA, with a central venous device (Implantable chamber, central venous jugular, femoral, subclavian, PICCline, dialysiscatheter) or a Midline and having catheter-related bacteremia
  • Catheter-related bacteremia according to the following definition (ePOPI): Positiveblood cultures within 48 hours of a suspected catheter infection (or its removal) Withone of the following criteria: - Before catheter removal: differential time ofpositivity of central/peripheral blood cultures ≥ 2 hours
  • After catheter removal: positive catheter culture ≥ 103 CFU/ml, with the sameorganism.
  • Patient transportable for ultrasound or ultrasound can be performed in the patient'sbed
  • Patient capable of giving consent, or consent of the trusted person for patients notcapable of giving consent at the time of inclusion
  • Written consent signed by the participant and the investigator
  • Person affiliated to social security

Exclusion

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

Total Participants: 120
Treatment Group(s): 1
Primary Treatment: Doppler ultrasound
Phase:
Study Start date:
May 31, 2023
Estimated Completion Date:
June 30, 2026

Connect with a study center

  • CHU Angers

    Angers, 49000
    France

    Site Not Available

  • Centre Hospitalier Le Mans

    Le Mans, 72 000
    France

    Active - Recruiting

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