Superficial Vein Thrombosis of the Upper Limb in Bacteremia Associated With PICCline and Midline Catheters: Frequency and Clinical Consequences
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Frequency of unfavorable outcomes according to the presence or absence of superficial venous thrombosis (SVT)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 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
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Catheter Associated Infection
干预措施: Follow-up for catheter-related bacteremia (Other)
结局指标
主要结局
Frequency of unfavorable outcomes according to the presence or absence of superficial venous thrombosis (SVT)
时间窗: At day 28 after completion of treatment for catheter-related bacteremia
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.
次要结局
- Describe the risk factors associated with the occurrence of deep vein thrombosis.(At day 28 after completion of treatment for catheter-related bacteremia)
- Describe the imaging findings and the evolution of catheter-related deep vein thrombosis(At day 14 after completion of treatment for catheter-related bacteremia)