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临床试验/NCT01661361
NCT01661361Unknown不适用

Optimalisation of Therapeutic Drug Monitoring (TDM) of Vancomycin in Patients With Central Venous Port Devices

Universitaire Ziekenhuizen KU Leuven0 个研究点目标入组 15 人开始时间: 2012年9月最近更新:
适应症

试验速览

阶段
不适用
入组人数
15
主要终点
comparison of central (via port device) and peripherally obtained vancomycin levels: the difference, when using the new flushing technique, is allowed to be maximally 0.5 mg/L

研究概览

简要总结

Recently, it was reported that when vancomycin levels are determined after port sampling, levels can be falsely increased potentially leading to wrong dose adjustments.

The investigators conducted an in vitro experiment using several central venous port devices, in which different flushing techniques were evaluated yielding residual vancomycin levels of less than 0.5 mg/L.

In this study, the investigators want to evaluate this flushing technique in vivo in 15 patients admitted with catheter-related infection and treated with systemic vancomycin and vancomycin antibiotic lock.

The purpose is to assess if correct flushing can avoid spurious vancomycin levels obtained via port sampling.

研究设计

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

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 patients,
  • having central venous port device,
  • treated with systemic vancomycin in combination with vancomycin antibiotic lock

排除标准

  • pregnant women,
  • children,
  • patients with 'do not resuscitate' (DNR) code

结局指标

主要结局

comparison of central (via port device) and peripherally obtained vancomycin levels: the difference, when using the new flushing technique, is allowed to be maximally 0.5 mg/L

时间窗: central and peripheral vancomycin levels will be obtained during steady state: this means starting from the 4th dose (= day 2) of vancomycin treatment. Vancomycin is usually given during 14 days after the last positive blood culture.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Isabelle Spriet

PharmD, PhD

Universitaire Ziekenhuizen KU Leuven

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