Superficial Vein Thrombosis of the Upper Limb in Bacteremia Associated With PICCline and Midline Catheters: Frequency and Clinical Consequences
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Follow-up for catheter-related bacteremia.
- Who it may be relevant to
- Registry conditions: Catheter Associated Infection. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other Follow-up for catheter-related bacteremia
Clinical follow-up and outcomes of patients with catheter-related bacteremia
Primary outcome measures
- Frequency of unfavorable outcomes according to the presence or absence of superficial venous thrombosis (SVT) [Time frame: At day 28 after completion of treatment for catheter-related bacteremia]
Secondary outcome measures (2)
- Describe the risk factors associated with the occurrence of deep vein thrombosis. [Time frame: At day 28 after completion of treatment for catheter-related bacteremia]
- Describe the imaging findings and the evolution of catheter-related deep vein thrombosis [Time frame: At day 14 after completion of treatment for catheter-related bacteremia]
Eligibility criteria
Inclusion criteria
- 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.
- Affiliation with a social security system
- No objection to the study
Exclusion criteria
- 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.
- Inability to perform the initial routine Doppler ultrasound
- Withdrawal of the patient's consent
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Screening
Study locations
France · 1 center
- CHU de NICE — Nice
Identifiers
NCT: NCT07388381 · 25-PP-07