跳至主要内容
临床试验/NCT04470973
NCT04470973招募中不适用

Population Pharmacokinetics of Amikacin and Cefuroxime in Critically Ill Septic Patients Admitted to the ICU or the ED

Radboud University Medical Center1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年7月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
1
主要终点
To describe the population pharmacokinetics of amikacin in Intensive Care or Emergency Department patients

研究概览

简要总结

Infections in critically ill patients are a major healthcare problem and an important source of morbidity and mortality. Since critically ill patients often have altered pharmacokinetics (PK) compared to non-critically ill patients there is a substantial risk that present standard dosing regimens of antibiotics lead to suboptimal outcomes for patients on the ICU or the ED. To prevent the risk of inadequate dosing in ICU patients, it is important to fully understand the PK of antibiotics in this vulnerable group in order to optimize the dosing regimens.

With this study, the investigators will describe the pharmacokinetics of cefuroxime and amikacin in ICU and ED patients. A heterogeneous population of ICU and ED patients will be included to be able to find which factors might influence the pharmacokinetics of these drugs and to what extent. By using population modeling the investigators will simulate different dosing regimens and MIC values and compare probability of target attainment between each of these dose and MIC combinations. This will allow the investigators to optimize dosing regimens of cefuroxime and amikacin in critically ill patients.

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

  • The patient is admitted to the ICU or ED;
  • The patient is at least 18 years of age on the day of inclusion;
  • Is managed with a central venous catheter or arterial line;
  • Is treated with amikacin and/or cefuroxime as standard care.

排除标准

  • Has previously participated in this study.

研究组 & 干预措施

Cefuroxime/Amikacin

20 patients will be included in the cefuroxime cohort and 20 patients in the amikacin cohort.

干预措施: Cefuroxime (Drug)

Cefuroxime/Amikacin

20 patients will be included in the cefuroxime cohort and 20 patients in the amikacin cohort.

干预措施: Amikacin (Drug)

结局指标

主要结局

To describe the population pharmacokinetics of amikacin in Intensive Care or Emergency Department patients

时间窗: 1 year

To describe the population pharmacokinetics of cefuroxime in Intensive Care or Emergency Department patients

时间窗: 1 year

次要结局

  • To determine the proportion of patients who attain adequate PK/PD targets in relation to the MIC of the suspected pathogen.(1 year)
  • To determine the toxicity of amikacin(1 year)
  • To determine the influence of renal clearance and weight on the pharmacokinetics of amikacin and cefuroxime(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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