Impact of Infusion Line Change Frequency on Infectious Complications Related to Central Venous Catheters in the Intensive Care Unit ICU
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,830
- 试验地点
- 27
- 主要终点
- Rate (%) of patients with with a central venous catheter-related infectious complication
研究概览
简要总结
In the intensive care unit, patients' care and secure drugs administration require a central venous catheter. These invasive devices can lead to complications, particularly infections. Most preventive recommendations focus on catheter insertion, line handling, and dressings. Few recommendations adress catheter dwell time, which is certainly the main source of infection. Part of the prevention strategy is the regular and systematic replacement of infusion sets , as they may become contaminated during use, mainly through the hands of healthcare professionals. Prolonged use increases the risk of infection. Infusion lines changes involve disconnecting the old sets, discarding infusion devices containing drug residues, and replacing them with new sterile devices.
Current international guidelines recommend replacing these sets every 4 days, and the Center for Disease Control and Prevention recommends not exceeding 7 days. Replacing these devices requires the time of qualified nurses, numerous sterile medical devices, and medications. In addition to the intended effect on infection prevention, the procedure has impacts on workload and costs.
The objective of the study is to demonstrate that changing infusion set every 7 days does not increase the rate of central venous catheters related infections compared with changing infusion set every 4 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- •Adult patient
- •Any ICU patient with a central venous catheter (inserted by venipuncture) in place for less than 72 hours and with an expected dwell time of at least 7 days
- •Patient affiliated with or covered by a social security system
- •Patient who has given verbal consent or written consent from a third party or in the event that the patient is unable to give consent.
排除标准
- •Patient with a documented bloodstream infection at the time of inclusion
- •Patient whose central venous catheter has been in place for more than 72 hours
- •Patient with suspected catheter-related infection
- •Patient whose study catheter was inserted using a guidewire exchange
- •Patient previously enrolled in the study during the same ICU stay
- •Patient whose condition, according to the clinician, does not allow safe placement of a central venous catheter, such as:
- •Allergy to catheter material
- •Confirmed deep vein thrombosis at the time of insertion
- •Inflammatory skin disorder at the insertion site
- •Patient admitted for extensive burns
- •Inadequate understanding of the French language
- •Pregnant, breastfeeding, or postpartum woman
- •Person deprived of liberty by judicial or administrative decision
- •Person receiving involuntary psychiatric care
- •Person under legal guardianship or other legal protection measure
研究组 & 干预措施
7-day infusion set replacement
Infusion sets connected to the central venous catheter will be replaced every 7 days.
干预措施: 7-day Infusion set replacement (Procedure)
4-day infusion set replacement
Infusion sets connected to the central venous catheter will be replaced every 4 days.
干预措施: 4-day infusion set replacement (Procedure)
结局指标
主要结局
Rate (%) of patients with with a central venous catheter-related infectious complication
时间窗: From central venous catheter insertion until 48 hours after catheter removal during the ICU stay (censored at 90 days).
Infectious complications include: 1. Catheter-related infections (CRI) defined as: * A positive catheter culture, with quantitative culture ≥10³ CFU/ml (Brun-Buisson technique) or, if not available, a semi-quantitative culture \>15 CFU (Maki technique), and purulence at the catheter insertion site or tunnelitis. Or * A positive catheter culture, with quantitative culture ≥10³ CFU/ml (or semi-quantitative culture \>15 CFU), and complete or partial regression of systemic signs of infection within 48 hours after catheter removal. 2. Catheter-related bloodstream infections (bacteremia or fungemia) defined as: * The occurrence of bacteremia (or fungemia) within 48 hours before or after catheter removal (or suspected catheter-related infection if the catheter is not immediately removed), And * Either a positive culture with the same microorganism from the insertion site or catheter, with ≥10³ CFU/ml (Brun-Buisson technique) or, if not available, a semi-quantitative culture
次要结局
- Central line-associated bloodstream infection (CLABSI)(Day 90)
- Non-central line-associated bloodstream infection(Day 90)
- Catheters with catheter colonization(From central venous catheter insertion until 48 hours after catheter removal during the ICU stay (censored at 90 days).)
- Time to onset of central venous catheter-related infectious complication(Day 90)
- ICU length of stay(Day 90)
- All-cause ICU mortality(Day 90)
- Cumulative nursing time related to infusion set replacements(1000 days)
- Cost of materials required for infusion set replacements(1000 days)