: Pharmacokinetics of Ceftazidime-Avibactam in Critically Ill Patients With Renal Failure Requiring Continuous Venovenous Hemodiafiltration
试验速览
- 阶段
- 不适用
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Avibactam effluent concentrations
研究概览
简要总结
The study's primary objective is to determine plasma and dialysis fluid concentrations in patients prescribed ceftazidime-avibactam as the standard treatment for their infection and requiring continuous venovenous hemodiafiltration (CVVHDF) as part of the standard treatment for acute or chronic renal failure. Secondarily, the study will evaluate the pharmacokinetics of ceftazidime-avibactam in these patients on CVVHDF. The study will also determine if the prescribed dose meets pharmacodynamic targets.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Adults > 18 years of age
- •Patients requiring continuous renal replacement therapy (CRRT) due to acute or chronic renal failure
- •documented or suspected infection requiring a prescription for ceftazidime-avibactam
排除标准
- •Patients on CRRT < 24 hours
- •Patients on ceftazidime-avibactam < 24 hours
- •Patients unable to remain on CRRT for 32 hours continuously without clotting
研究组 & 干预措施
Ceftazidime and Avibactam
Ceftazidime-avibactam pharmacokinetic monitoring
干预措施: Ceftazidime-avibactam (Drug)
结局指标
主要结局
Avibactam effluent concentrations
时间窗: At hours post dose: 0, 2, 3, 4, 6, 8 on or after Day 2 of therapy (i.e. during the fourth dose)
mg/L
Ceftazidime plasma concentrations
时间窗: At hours post dose: 0, 2, 3, 4, 6, 8 on or after Day 2 of therapy (i.e. during the fourth dose)
mg/L
Avibactam plasma concentrations
时间窗: At hours post dose: 0, 2, 3, 4, 6, 8 on or after Day 2 of therapy (i.e. during the fourth dose)
mg/L
Ceftazidime effluent concentrations
时间窗: At hours post dose: 0, 2, 3, 4, 6, 8 on or after Day 2 of therapy (i.e. during the fourth dose)
mg/L
次要结局
- Half-life (t1/2)(8-hours)
- Minimum plasma concentration (Cmin)(At hours post dose: 0, 2, 3, 4, 6, 8 on or after Day 2 of therapy (i.e. during the fourth dose))
- Sieving Coefficient(8-hours)
- Maximum plasma concentration (Cmax)(At hours post dose: 0, 2, 3, 4, 6, 8 on or after Day 2 of therapy (i.e. during the fourth dose))
- Number of participants with adverse effects as a measure of safety(Days 1-30)
- Clearance (Cl)(8-hours)
- AUC 0 to 8 hours(8-hours)