Population Pharmacokinetics and Pharmacodynamics Study of Piperacillin/Tazobactam During Early Phase in Critically Ill Patients With Severe Sepsis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Concentration of piperacillin in plasma
研究概览
简要总结
This is prospective study to assess the pharmacodynamics (t>MIC) of 4.5 g every 6 h of piperacillin/tazobactam in patients with early phase of severe sepsis/septic shock following administration by a 30 min infusion.
Clinical and laboratory data such as age, sex, body weight, electrolyte, vital signs, APACHAE II score, BUN, Cr and fluid balance will be collected.
Fifty patients will be enrolled in this study. Piperacillin pharmacokinetic study will be carried out during the piperacillin/tazobactam therapy.
Each patient received 4.5 g every 6 h of piperacillin/tazobactam within 24 h of severe sepsis or septic shock, blood samples (approximately 3 ml) will be obtained by direct venipuncture at the following time: 0, 0-0.5, 0.5-2, 2-4 and 4-6 h after piperacillin/tazobactam therapy.
Concentration of piperacillin in plasma will be simulated in Monte Carlo technique to get PK/PD index and reported to % PTA and % CFR.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •sepsis patient (defined by 2011 SCCM/ESICM/ACCP/ATS/SIS International sepsis definition conference)
- •severe sepsis or septic sock was defined by
- •Severe sepsis (sepsis with organ dysfunction)
- •Septic shock (sepsis with systolic arterial pressure<90 mmHg, mean arterial pressure<60 mmHg or decrease systolic blood pressure> 40 mmHg from base line)
排除标准
- •Patients who are pregnant.
- •Patients who have documented hypersensitivity to beta-lactam
- •Patients who are dialysis
- •Patients who are severe sepsis or septic shock more than 24 hour
研究组 & 干预措施
piperacillin/tazobactam
4.5 g of piperacillin/tazobactam in 100 ml of normal saline solution was administered via an infusion pump at a constant flow rate 30 min every 6 h
干预措施: Piperacillin-tazobactam (Drug)
结局指标
主要结局
Concentration of piperacillin in plasma
时间窗: 6 hour after the piperacillin dose
Concentration of piperacillin in plasma will be simulated in Monte Carlo simulation to assess PK/PD index as 40% and 100% T\>MIC and will be reported as %PTA.
次要结局
未报告次要终点
研究者
Sutep Jaruratanasirikul
Principal Investigator
Prince of Songkla University