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临床试验/ACTRN12613000241730
ACTRN12613000241730已完成2 期

Multi-national prospective pharmacokinetic study, improving antibiotic dosing in renal replacement therapy for the five most commonly prescribed antibiotics Piperacillin-Tazobactam, Meropenem, Vancomycin and Imipenem and Linezolid at selected sites.

artional Health and Medical research Council0 个研究点目标入组 450 人开始时间: 2013年2月28日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
450

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Non-randomised trial
主要目的
Treatment
盲法
Open (masking not used)

入排标准

年龄范围
18 Years 至 o limit(—)
性别
All

入选标准

  • 1.Age 18 years or older
  • 2.Acute kidney injury requiring renal replacement therapy (defined according to published RIFLE, AKIN or KDIGO criteria)
  • 3.Clinical indication for IV Piperacillin-Tazobactam, Meropenem or Vancomycin
  • 4.Expected to be on filter for at least 4 days
  • 5.Presence of intra-arterial line for blood sampling if renal replacement therapy filter port sampling not possible
  • 6.Informed consent from patient or patient’s authorized representative

排除标准

  • 1. Imminent death/not expected to survive etc.
  • 2. Major bleeding or Haemoglobin <70g/L or platelets <20 x103/mm3.
  • 3.Regular dosing with any of the 5 study antibiotics for greater than 36 hours, within the 7 days prior to enrolment
  • 4. Unable to obtain consent

研究者

发起方
artional Health and Medical research Council

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