NCT02042599Unknown2 期
Pharmacokinetic Study of 48-hour Sevoflurane Inhalation Using a Disposable Delivery System (AnaConDa©) in ICU Patients With Acute Kidney Injury
University Hospital, Clermont-Ferrand1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2014年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Determination of plasmatic concentrations of sevoflurane before using AnaConda® system
研究概览
简要总结
Describing a pharmacokinetic model of 48-h sevoflurane sedation in ICU patients with acute kidney failure
详细描述
Prospective clinical monocentric study in ICU with sedated ventilated patients (presenting acute kidney failure) with sevoflurane during 48 h with the AnaConda® system, establishing pharmacokinetic model of sevoflurane and its metabolites (hydroxyfluroisopropanol, fluoride)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Adult patients ventilated more than 48 h Stable respiratory and hemodynamic conditions Consent of patients or family Arterial line AKIN score = 3
排除标准
- •BMI <30 Sevoflurane anaphylaxia
研究组 & 干预措施
sevoflurane
Experimental
Determination of plasmatic concentrations of sevoflurane at different times of a 48h sedation of sevoflurane in ICU patients with acute kidney injury
干预措施: Sedation with sevoflurane during 48-hr in ICU (Drug)
结局指标
主要结局
Determination of plasmatic concentrations of sevoflurane before using AnaConda® system
时间窗: at 5min, 60 min, 24 hrs and just before the end of sedation.
次要结局
- Determination of plasmatic concentrations of HFIP and fluoride(at 5min, 15 min, 60 min and just before the end of sedation. And 5 min, 10 min, 30 min, 120 min and 360 min after the end of sedation)
研究者
研究点 (1)
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