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临床试验/DRKS00011159
DRKS00011159已完成3 期

Therapeutic drug monitoring-based dose optimisation of piperacillin in patients with severe sepsis or septic shock to investigate effects on organ functions and survival: a prospective, multicenter, randomized controlled trial - Target

Friedrich-Schiller-Universität Jena0 个研究点目标入组 254 人开始时间: 2016年10月10日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
254

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
Randomized controlled study
盲法
Blinded (masking used)

入排标准

年龄范围
18 Years 至 one(—)
性别
All

入选标准

  • Patients with severe sepsis or septic shock
  • onset of severe sepsis or septic shock not longer than 24 hours prior
  • to randomization
  • Antimicrobial therapy with piperacillin planned or started
  • age =18 years
  • written informed consent of the patient or legal representative

排除标准

  • pregnant or breast-feeding women
  • anamnestic known hypersensitivity against beta-lactam antibiotics or another part of the investigational medicinal product
  • previous treatment with piperacillin (in combination with tazobactam) > 24 hours before randomization
  • participation in another interventional clinical trial
  • previous participation (TARGET)
  • limits of therapy or cessation
  • impaired liver function (Child-Pugh C)
  • life expectancy < 28 day due to accompanying illnesses
  • piperacillin-measurement impossible within 24 hours after randomization

研究者

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