Superficial Vein Thrombosis of the Upper Limb in Bacteremia Associated With PICCline and Midline Catheters: Frequency and Clinical Consequences

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire de Nice

About this trial

The use of long-term peripheral venous catheters inserted in the upper limb (PICC lines and Midlines) has increased markedly over recent years.

Catheter-related bacteremias and venous thromboses are the main complications associated with these catheters. These events may occur independently or simultaneously. In addition, venous thromboses may involve the superficial venous system (SVT) or the deep venous system (DVT).

Current guidelines define septic thrombophlebitis as the association of a bacteremia and a DVT along the venous course of the catheter. This represents a severe complication of catheter-related bacteremia, leading to a modification in the duration of antibiotic therapy. However, SVTs associated with catheter-related bacteremias along the catheter pathway are not included in the definition of septic thrombophlebitis and are not addressed by specific recommendations.

The objective of this study is therefore to assess the impact of upper-limb SVT on the frequency of unfavorable outcomes in catheter-related bacteremias related to PICC and Midline catheters, in order to determine whether superficial venous thrombosis occurring in the context of a catheter-related bacteremia should be considered a distinct entity not falling under the diagnosis of septic thrombophlebitis (and therefore not requiring a modification of antibiotic treatment duration, in accordance with current guidelines), or whether, conversely, it should be considered equivalent to septic thrombophlebitis, as is the case for deep venous thrombosis.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

Hospitalization in a department of Nice University Hospital

Expected length of hospitalization ≥ 72 hours

Diagnosis of catheter-related bacteremia on PICCline or Midline.

Disqualifiers

Pregnant or breastfeeding women

Legal protection measures (patients under guardianship, trusteeship, or judicial protection)

Inability to remove the catheter

Doppler ultrasound showing DVT in the upper limb at selection.

Trial design

Design model

Single group

Treatments tested in this trial

  • Follow-up for catheter-related bacteremia

    Other intervention

    Clinical follow-up and outcomes of patients with catheter-related bacteremia

Treatment groups

150 Participants
are divided into 1 treatment group
Group A: Catheter Associated InfectionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Frequency of unfavorable outcomes according to the presence or absence of superficial venous thrombosis (SVT)

An unfavorable outcome is defined as a composite endpoint including at least one of the following: * Relapse of bacteremia documented with the same microorganism and/or * Extension of superficial venous thrombosis to the deep venous system (deep vein thrombosis and/or pulmonary embolism) and/or * Infectious complications related to the initial diagnosis of catheter-related bacteremia, including infective endocarditis, deep abscess, septic thrombophlebitis, osteoarticular infection, or any other complication related to CRBSI, and/or * Septic shock.

Time frame
At day 28 after completion of treatment for catheter-related bacteremia

Secondary outcomes

1

Describe the risk factors associated with the occurrence of deep vein thrombosis.

Comparison of patient parameters and management with the course of catheter-related bacteremia

Time frame
At day 28 after completion of treatment for catheter-related bacteremia
2

Describe the imaging findings and the evolution of catheter-related deep vein thrombosis

Comparison of echo-doppler imaging between inclusion and 14 days after antibiotics treatment

Time frame
At day 14 after completion of treatment for catheter-related bacteremia

Other outcomes

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