Pharmacokinetics of Tigecycline in Critical Ill Patients Undergoing Continuous Renal Replacement Therapy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Tigecycline Steady State Plasma Concentrations
研究概览
简要总结
The aim of this study is to determine the Pharmacokinetics/Pharmacodynamics(PK/PD) of tigecycline in critical ill patients undergoing continuous renal replacement therapy（CRRT）and examine whether the dosage needs adjustment.
The study will observe two groups of patients respectively and compare the difference between them. Patients who need to receive CRRT when treat with high-dose tigecycline will be collected in Group CRRT. Patients who treat with high-dose tigecycline only will be collected in Group non-CRRT.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-75 years,hospitalized ICU patients, male or female;
- •having definitive diagnosis to treat with tigecycline for bacterial infection;
- •receiving CRRT with renal insufficiency or not receiving CRRT with normal renal function.
排除标准
- •Patients with Child-Pugh C cirrhosis;
- •Allergic to tetracycline or tigecycline;
- •Patients received CRRT for < 3 days or treated with tigecycline < 3 days;
- •Patients who are pregnant.
研究组 & 干预措施
Group CRRT
Patients who need to treat with tigecycline for bacterial infection, have renal insufficiency and have to treat with CRRT
干预措施: Tigecycline (Drug)
Group non-CRRT
Patients who need to treat with tigecycline for bacterial infection, have normal renal function in ICU and have no need to treat with CRRT
干预措施: Tigecycline (Drug)
结局指标
主要结局
Tigecycline Steady State Plasma Concentrations
时间窗: Day 1-3
Steady State Plasma Concentration(Css) in blood
次要结局
- Area Under the Plasma Concentration versus Time Curve(AUC)(Day 1-3)
- Minimal Inhibitory Concentration(MIC)(Day 1-3)
- Peak Plasma Concentration(Cmax) of Tigecycline in blood(Day 1-3)
- Trough Plasma Concentration(Cmin) of Tigecycline in blood(Day 1-3)