Understanding septic thrombophlebitis in patients with central venous catheters
Description of Septic Thrombophlebitis on Central Venous Catheter and Midline
This study is trying to understand a serious infection related to central venous catheters in hospitalized adults to improve treatment and outcomes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier le Mans Academic / other |
| Locations | 2 sites (Angers and 1 other locations) |
| Trial ID | NCT05743738 on ClinicalTrials.gov |
What this trial studies
This study focuses on septic thrombophlebitis, a serious complication arising from central venous catheters, which can lead to increased morbidity and mortality. It aims to characterize the condition using Doppler ultrasound to better understand its frequency and implications in hospitalized patients. By identifying the presence of thrombosis associated with catheter-related bacteremia, the study seeks to improve treatment protocols and patient outcomes. The research will involve adult patients with central venous devices who exhibit signs of infection.
Who should consider this trial
Good fit: Ideal candidates include hospitalized adults with a central venous device and confirmed catheter-related bacteremia.
Not a fit: Patients without a central venous catheter or those not experiencing catheter-related infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnosis and management of septic thrombophlebitis, potentially reducing complications and enhancing patient care.
How similar studies have performed: While the specific approach of using Doppler ultrasound for this condition may be novel, similar studies have indicated the importance of early diagnosis and management of catheter-related infections.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Angers and 1 other locations
- CHU Angers — Angers, France (Not_yet_recruiting)
- Centre Hospitalier Le Mans — Le Mans, France (Recruiting)
Study contacts
- Study coordinator: Christelle JADEAU
- Email: cjadeau@ch-lemans.fr
- Phone: +33244710781
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.