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
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