ACTRN12614000225617尚未招募2 期
A randomised controlled pilot trial of early goal-directed sedation in paediatric intensive care.
Australia and NewZealand Intensive Care-Research Centre (ANZIC-RC)0 个研究点目标入组 60 人开始时间: 2014年3月3日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- Days 至 15 Years(—)
- 性别
- All
入选标准
- •Children requiring sedation to facilitate mechanical ventilation in intensive care.
- •Subject has been mechanically ventilated for less than 12 hours
- •Patient is expected to remain mechanically ventilated for more than 24 hours
排除标准
- •Age 16 years or older
- •Proven or suspected acute primary brain lesion that may result in global impairment of conscious level or cognition, such as traumatic brain injury, intracranial haemorrhage, intracranial infection or hypoxic brain injury.
- •Proven or suspected neurological injury or pathology that may result in permanent or prolonged weakness of upper and lower limbs.
- •Burn injuries
- •Receiving or expected to need continuous neuromuscular blockade
- •Allergy to dexmedetomidine
- •Cardiovascular instability as manifested by any of the following:
- •a.Mean arterial blood (MAP) pressure less than 2 standard deviations below the normal mean for age despite resuscitation and vasopressor therapy
- •b.Heart rate (HR) less than 2 standard deviations below normal for age
- •c.Atrio-ventricular block (2nd or 3rd degree) in the absence of a functioning pacemaker
- •End stage liver failure or acute fulminant hepatic failure
- •A history of a chronic brain process that has resulted in severe global impairment of conscious level or cognition, and may include CP, metabolic conditions, and progressive neurological disorders
- •Patient is on ECLS
- •Death is deemed imminent and inevitable
- •There is an underlying disease that makes survival to 90 days unlikely
研究者
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