NCT00747721已完成1 期
Pharmacokinetics of Intravenous Dexmedetomidine for Prolonged Infusion in Critically Ill, Ventilated Patients in Intensive Care Unit; an Open, Non-Randomised, Single Centre Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Pharmacokinetic variables.
研究概览
简要总结
The study will examine dexmedetomidine levels in the blood of critically ill intensive care patients to understand how it is broken down by the body.
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
- Basic Science
- 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
- •Written informed consent obtained from the patient's legal representative according to local regulations before starting any study procedures other than pre-screening
- •Patients sedated and ventilated in ICU for whom sedation is expected to be clinically required for at least 24 hours, as determined by the responsible physician
- •Prescribed light to moderate sedation (target RASS = 0 to -3)
排除标准
- •Acute severe intracranial or spinal neurological disorder due to vascular causes, infection, intracranial expansion or injury
- •Uncompensated acute circulatory failure at screening (severe hypotension with mean arterial pressure(MAP) < 55 mmHg despite vasopressor and inotrope therapy)
- •Heart rate (HR) < 50 beats/min for longer than 5 min between screening and starting study treatment
- •Atrioventricular (AV)-conduction block II-III (unless pacemaker installed)
- •Severe hepatic impairment (e.g. bilirubin > 101 μmol/L)
- •Need for continuous muscle relaxation
- •Any condition which would significantly interfere with the collection of study data
- •Burn injuries or other conditions requiring regular anesthesia or surgery
- •Use of centrally acting alpha-2 agonists or antagonists within 24 hours prior to starting the study (e.g. dexmedetomidine, clonidine, tizanidine, apraclonidine and brimonidine)
- •Known allergy to dexmedetomidine or any excipients of the study treatment
- •Patients who have or are expected to have treatment withdrawn or withheld due to poor prognosis
- •Patients receiving sedation for therapeutic indications rather than to tolerate the ventilator (e.g. epilepsy)
- •Patients unlikely to require continuous sedation during mechanical ventilation (e.g. Guillain-Barré syndrome)
- •Patients who are unlikely to be weaned from mechanical ventilation; e.g. diseases/injuries primarily affecting the neuromuscular function of the respiratory apparatus such as clearly irreversible disease requiring prolonged ventilatory support (e.g. high spinal cord injury or advanced amyotrophic lateral sclerosis)
研究组 & 干预措施
1
Experimental
Dexmedetomidine
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Pharmacokinetic variables.
时间窗: From start of treatment to 48 hr follow-up.
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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