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临床试验/NCT02446392
NCT02446392已完成不适用

The Distribution of Plasma Drug Concentrations of Beta-lactam Antibiotics in Intensive Care Unit Patients

Linkoeping University2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2014年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120
试验地点
2
主要终点
The rate of patients below 16mg/L for piperacillin-tazobactam, 2 mg/L for meropenem and 4mg/L for cefotaxim

研究概览

简要总结

In this project, intensive care unit (ICU) patients treated with beta-lactam antibiotics are included with the aim to investigate the potential underdosing in this patient group. Four regional ICU-clinics are recruiting consecutive patients (n=120) and samples are taken before the next dose is administered for three consecutive days.

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

  • Current treatment with beta-lactam antibiotics and admission to the ICU

排除标准

  • Pregnancy, age below 18 years

结局指标

主要结局

The rate of patients below 16mg/L for piperacillin-tazobactam, 2 mg/L for meropenem and 4mg/L for cefotaxim

时间窗: 3 days

次要结局

  • Mortality in relation to initial levels of beta-lactam antibiotics as defined in primary outcome(30 days)
  • The rate of patients below 100% time over MIC in relation to the bacteria causing the infection.(3 days)
  • Kidney function measured as eGFR in relation to initial levels of beta-lactam antibiotics as defined in primary outcome(3 days)
  • SAPS-score in relation to initial levels of beta-lactam antibiotics as defined in primary outcome(3 days)
  • Days in intensive care unit in relation to initial levels of beta-lactam antibiotics as defined in primary outcome(30 days)

研究者

发起方
Linkoeping University
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Thomas Schon

MD PhD (Associate professor)

Linkoeping University

研究点 (2)

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