Description of Septic Thrombophlebitis on Central Venous Catheter and Midline (NCT05743738) | Clinical Trial Compass
UnknownNot Applicable
Description of Septic Thrombophlebitis on Central Venous Catheter and Midline
France120 participantsStarted 2023-05-31
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study is tracking how long ultrasound signs of septic thrombophlebitis last on central venous catheters and midlines — does that mean it's mainly observational, and if so, what would participating actually involve for me day-to-day?
2Since the recruitment status for this trial is listed as unknown, can you find out whether it's still actively enrolling patients before we consider it as an option?
3The trial is focused on describing and measuring the condition rather than testing a specific treatment — so would joining this study affect or delay the treatment I'd receive for my septic thrombophlebitis?
4Because this is a descriptive study with no listed phase, what do we already know about how long septic thrombophlebitis on central venous catheters typically lasts, and would standard care be a more straightforward path for me right now?
5How often would I need ultrasound monitoring as part of this study, and is that level of follow-up something that realistically fits my current health situation and schedule?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evaluation of duration of ultrasound signs of septic thrombophlebitis on central venous catheter and midline