Colistimethate and Colistin Pharmacokinetics in Critically Ill Patients Undergoing Continuous Renal Replacement Therapy (CRRT)
试验速览
- 阶段
- 4 期
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Area under the curve (AUC)
研究概览
简要总结
The blood concentration of the antibiotic colistin is determined in patients in whom kidney function is reduced such that a renal replacement therapy is needed.
Hypothesis:no dose reduction is needed in patients undergoing continuous renal replacement therapy over 24h because colistin is sufficiently removed by this procedure.
详细描述
After administration of intravenous Colistin multiple blood samples are drawn over one dosing interval on day 1, 3, and 5 of treatment.
Patients are monitored for signs of neuro- and nephrotoxicity
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
- •male or female aged 18 years or older
- •hospitalised on the ICU
- •gram-negative infection requiring antibiotic therapy with intravenous colistin as part of their routine medical care
- •clinical necessity for continuous venovenous renal replacement therapy
排除标准
- •History of hypersensitivity to colistin or to other polymyxins
- •Personal or family history of Myasthenia Gravis
研究组 & 干预措施
colistin pharmacokinetics
Intravenous colistin 9 million units loading dose and 3 million units q8h maintenance dose as long as treatment of infection is required
干预措施: Colistin (Drug)
结局指标
主要结局
Area under the curve (AUC)
时间窗: predose, and 0.5, 1, 2, 4, 6, 8 hours after administration
次要结局
- Sings of neurotoxicity and nephrotoxicity(Expected average of follow up is about 14 days.)