First Dose Pharmacokinetics for Piperacillin and Meropenem in ICU Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Plasma clearance
研究概览
简要总结
The purpose of the study is to characterize the pharmacokinetics of meropenem and piperacillin in ICU-patients at the time of the first dose administration and to contrast that with the same measurements obtained in the same patient 2-3 days later during the course of ICU treatment.
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
- 否
入选标准
- •Patient being treated in one of the participating ICUs and planned to recieve treatment with meropenem or piperacillin.
- •Exclusion Criteria (fullfilling any exlusion criteria means that patient cannot be included in the study):
- •Not possible to retrospectively ask the patient or next of kin for consent to take part in the study or patient or next-of-kin not providing consent.
- •Not posisble to obtain and process blood samples as specified by protocol.
- •Ongoing renal replacement therapy.
- •Patient having received the same antibiotic within the previous 96 h.
排除标准
- 未提供
研究组 & 干预措施
Study Kohort
As specified by study population, inclusion and exclusion criteria
干预措施: Piperacillin/tazobactam, Meropenem (Drug)
结局指标
主要结局
Plasma clearance
时间窗: For the first antibiotic administration and if possible for a second administration 48-72 hour later.
Plasma clearance calculated from repeated plasma concentrations measurements and pharmacokinetic modelling.
Volume of distribution
时间窗: For the first antibiotic administration and if possible for a second administration 48-72 hour later.
Apparent volume of distribution calculated from repeated plasma concentrations measurements and pharmacokinetic modelling.
次要结局
- Plasma antibiotic concentrations at mid and end of dosing interval(For the first antibiotic administration and if possible for a second administration 48-72 hour later.)
研究者
Johan Petersson
Senior ICU consultant, Associate Professor
Karolinska University Hospital