NCT04178148已完成不适用
Personalized Dose Optimization of Amikacin Guided by Pharmacokinetic Modeling Software in Patients With Septic Shock
Centre Hospitalier Universitaire de Nīmes2 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2019年11月25日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Patients reaching target amikacin maximum concentration following second dose
研究概览
简要总结
Amikacin dose optimization is challenging in critically ill patients. The use of BestDose software algorithm-based drug optimization could help to achieve the recommended target concentrations (60-80 mg/L) after administration of the second dose of amikacin, associated with improved outcome. The study investigators hypothesize that 80% of patients undergoing drug dosing optimization using the BestDose software in the interventional group will reach the predefined PK/PD targets.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •The patient or their legal representative must have given their free and informed consent and signed the consent form
- •The patient must be a member or beneficiary of a health insurance plan
- •The patient has septic shock according to the SEPSIS-3 definition in the 24 hours preceding inclusion, regardless of the source of infection
- •Patient having already received a first dose of amikacin in the 22 preceding hours
- •Patient with an expectation of receiving at least 2 doses of amikacin
- •Patient with available amikacin therapeutic drug monitoring
排除标准
- •The subject is participating in an interventional study that could influence the primary outcome, or is in a period of exclusion determined by a previous study
- •The patient is pregnant, parturient or breastfeeding
- •Patient has a contra-indication or an allergy to treatment by amikacin
- •Patient is not expected to survive beyond 48 hours
结局指标
主要结局
Patients reaching target amikacin maximum concentration following second dose
时间窗: 30 minutes after second dose of amikacin
Yes/no; Cmax 60-80mg/l
次要结局
- Patients reaching target amikacin minimum concentration following third dose(24 hours after third dose of amikacin)
- Patients reaching target amikacin minimum concentration following second dose(24 hours after second dose of amikacin)
- Patients reaching target amikacin maximum concentration following third dose(30 minutes after third dose of amikacin)
- Time taken to reach recommended Cmax during amikacin therapy(Maximum 7 days)
- Clinical cure test(Day 7)
- Number of days without renal replacement therapy(Day 28)
- Number of days without vasopressors(Day 28)
- Number of days without mechanical ventilation(Day 28)
- Mortality(Day 28)
研究者
研究点 (2)
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