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临床试验/NCT07430215
NCT07430215进行中(未招募)不适用

Incidence of Nosocomial, Catheter-associated Bloodstream Infections Depending on the Use of Disinfectant Caps

BDH-Klinik Hessisch Oldendorf1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2026年3月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
120
试验地点
1
主要终点
Incidence of CLABSI episodes

研究概览

简要总结

In a worldwide, one-day, prospective point-prevalence study, a prevalence of 15.1% for hospital-acquired central line-associated bloodstream infections (HA-CLABSI) was determined in 13,796 patients across 1,265 intensive care units in 75 countries. According to reference data from the National Reference Center for Surveillance of Nosocomial Infections, an average of 1.2 HA-CLABSI episodes per 1,000 central venous catheter days occurred in German intensive care units between 2020 and 2024. Since the mean length of stay for the observed patients was 4 days, this value could be significantly higher for patients with longer stays, such as those undergoing neurological rehabilitation.

Besides economic consequences (costs of CLABSI treatment, extended treatment duration), bloodstream infections also have a significant impact on treatment outcomes. Studies show that patients have twice the mortality risk after a bloodstream infection - even after adjusting for disease severity - and that bloodstream infections are associated with longer stays in the intensive care unit and in the hospital.

Bloodstream infections occur when pathogenic germs enter the bloodstream. This can happen through entry via wounds (e.g., after trauma), via venous catheters (catheter-associated), or through other infections that spread systemically (e.g., infections in the lungs, abdomen, or urinary tract).

To reduce the risk of pathogenic germs entering the bloodstream from venous catheters via the access point, disinfection caps can be used. These caps are pre-treated with 70% isopropanol and packaged sterilely. According to an observational study, the use of such disinfection caps in an oncology clinic significantly reduced the rate of contaminated blood cultures (central venous catheters) from 2.5% (17 of 692) to 0.2% (1 of 470).

To reduce the risk of pathogenic germs entering the bloodstream from venous catheters, disinfection caps can be used. As part of quality-improvement measures, the use of disinfectant caps is planned in the neurological intensive care unit. The use of these caps therefore does not constitute a study intervention in the strict sense, but rather the implementation of a new in-house quality standard.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

性别
All
接受健康志愿者

入选标准

  • Stay in the neurological intensive care unit
  • Presence of a central venous catheter (CVC)
  • Written consent from the legal representative of the study participant (if the participant lacks capacity to consent) and/or from the study participant (if the participant is capable of consenting) for the use of routine data for quality and research purposes

排除标准

  • written objection to the use of routine data for quality and research purposes

研究组 & 干预措施

CLABSI-C

Control cohort before use of desinfection caps

干预措施: sterile catheter cap (Other)

CLABSI-T

Test cohort with use of desinfection caps

干预措施: use of desinfection caps (Other)

结局指标

主要结局

Incidence of CLABSI episodes

时间窗: 1 year

次要结局

未报告次要终点

研究者

发起方
BDH-Klinik Hessisch Oldendorf
申办方类型
Other
责任方
Sponsor

研究点 (1)

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