Pharmacokinetics of Piperacillin and Tazobactam in Anuric Septic Patients Treated by Continuous Veno Venous Hemodiafiltration
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Serum levels of both piperacillin and tazobactam (Cmin) during 2 daus
研究概览
简要总结
The pharmacokinetics of piperacillin/tazobactam will be evaluated in twenty septic patients with renal failure undergoing continuous veno-venous hemodiafiltration.
详细描述
The pharmacokinetics of piperacillin/tazobactam will be evaluated in twenty septic patients with renal failure undergoing continuous veno-venous hemodiafiltration. This is a prospective study.
Continuous replacement therapy has a continuous effect on drug elimination which could compromise effective antibiotic treatment.
Patients will receive a standard course of pip/tazo 4g intravenously 8 hourly administrated immediately when CVVHDF will be started.
Blood samples will be collected at 30mn, 2h, 4h, 6h, 8h, 16h, 24h for the first and the second day.
We will measure plasma piperacillin/tazobactam concentration and compare them to MICs for the whole dosing interval.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •18 years of age and older .
- •Females of childbearing potential must have a negative pregnancy test at screening.
- •Subjects whose life expectancy is estimated over 7 days.
- •Anuric patients requiring continuous venovenous hemodiafiltration
- •Septic patients,severe sepsis or septic shock
- •Written informed consent should be given either by the patient or a member of his family
排除标准
- •Subjects with a history of true allergy or adverse drug reactions
- •Pathogens whose antibiotic susceptibility is not proved.
- •Patients having impaired hepatic function
- •Contraindication of anticoagulation by heparin
- •Residual renal function
- •Participation in a clinical trial
- •Interruption of treatment by piper/tazo or hemodiafiltration during the study.
- •Patients with psychiatric disorder or serious medical condition which in the opinion of the investigator may lead to complexity in patient management.
研究组 & 干预措施
Pharmacokinetic
干预措施: piperacillin/tazobactam (Drug)
Pharmacokinetic
干预措施: Pharmacokinetic (Procedure)
结局指标
主要结局
Serum levels of both piperacillin and tazobactam (Cmin) during 2 daus
时间窗: 2 days
次要结局
- Body clearance(2 days)