NCT00714857已完成2 期
Population Pharmacokinetics of Dexmedetomidine in ICU Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Pharmacokinetic parameters
研究概览
简要总结
Dexmedetomidine is a new, highly selective and potent alpha2-adrenoreceptor agonist registered for sedation of patients in intensive care units. Although the pharmacokinetics of dexmedetomidine have been studied previously also in an ICU setting, there is no information on the pharmacokinetics of long-lasting (>48 hours) dexmedetomidine infusions in humans.
The aim of this study is to study the pharmacokinetics of long-lasting dexmedetomidine infusions in ICU patients using the population pharmacokinetics approach.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Age ≥ 18 years.
- •Need for dexmedetomidine sedation (determined by the responsible physician).
- •Predicted length of dexmedetomidine sedation ≥ 48 hours.
- •Written informed consent from the patient or the relatives of the participating patient.
排除标准
- •A previous history of intolerance to the study drug or related compounds and additives.
- •Existing significant haematological, endocrine, metabolic or gastrointestinal disease
研究组 & 干预措施
1
Experimental
Patients receiving dexmedetomidine sedation
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Pharmacokinetic parameters
时间窗: Blood samples are taken three times daily for characterizing the pharmacokinetic parameters
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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