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临床试验/NCT05743738
NCT05743738招募中不适用

Description of Septic Thrombophlebitis on Central Venous Catheter and Midline

Centre Hospitalier le Mans4 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2023年5月31日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
120
试验地点
4
主要终点
Evaluation of duration of ultrasound signs of septic thrombophlebitis on central venous catheter and midline

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Evaluation of duration of ultrasound signs of septic thrombophlebitis on central venous catheter and midline

时间窗: Day 90

the duration is measured by time from the day of diagnosis of septic thrombophlebitis to the day of disappearance of signs of thrombophlebitis on Doppler ultrasound

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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