Pharmacokinetics of Anti-infectives in Critically Ill Patients in Need of Continuous Renal Replacement Therapy (CRRT) or Without CRRT
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 640
- 试验地点
- 1
- 主要终点
- Sub-therapeutic levels of measured antiinfectiva
研究概览
简要总结
The main purpose of the study is to examine if changes in pharmacokinetics of important antiinfectives in Critically Ill patients in need of continuous renal replacement therapy (CRRT), causes inadequate concentrations in plasma.
The effect of different modus of CRRT: CVVH and CVVHD will be compared, as well as type of filter, filter lifetime etc.
Hypothesis: The risk of incorrect dosage of antiinfectives - to low/ to high- is increased in critically ill patients receiving CRRT. Inadequate plasma concentrations of antiinfectives may contribute to increased mortality in this group.
详细描述
The main purpose of the study is to examine if changes in pharmacokinetics of important antiinfectives in Critically Ill patients in need of continuous renal replacement therapy (CRRT), causes inadequate concentrations in plasma.
The effect of different modus of CRRT: CVVH and CVVHD will be compared, as well as type of filter, filter lifetime etc.
Hypothesis: The risk of incorrect dosage of antiinfectives - to low/ to high- is increased in critically ill patients receiving CRRT. Inadequate plasma concentrations of antiinfectives may contribute to increased mortality in this group.
The antiinfectives to be examined are meropenem, fluconazol, cefotaxim, ciprofloxacin, tazobactam-piperacillin, vancomycin,penicillin,cloxacillin.
Endpoints:
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
- •Patients admitted to ICU in need of antiinfectives:
- •in need of CRRT
- •without acute kidney failure
- •requirement for antiinfectives> 72 hrs
- •Age > 18 yrs
- •signed informed consent
排除标准
- •Acute or chronic renal failure not in need of CRRT
- •Age < 18 yrs
结局指标
主要结局
Sub-therapeutic levels of measured antiinfectiva
时间窗: 72 hours
Pharmacokinetic/pharmacodynamic index achieved for each antiinfectiva
次要结局
- Mortality(90-days)
- SOFA-score(72 hrs)