NCT01707953已完成3 期
Efficacy of Midodrine for the Prevention of Orthostatic Hypotension During Early Mobilization After Fast-track Hip Arthroplasty - a Randomized, Placebo Controlled Trial.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- Orthostatic hypotension
研究概览
简要总结
The aim of this study is to examine the efficacy of 5 mg Midodrine (Gutron) vs. placebo on reducing the incidence of orthostatic hypotension during mobilization 6 h after a total hip arthroplasty.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Scheduled for primary unilateral hip arthroplasty
- •Age >= 18 years
- •Able to give informed consent
排除标准
- •General anaesthesia for the current procedure
- •Digoxin treatment.
- •history of renal or hepatic failure
- •history of glaucoma
- •history chronic urinary retention requiring treatment
- •history of orthostatic intolerance / hypotension
- •other autonomous nervous system disease
- •alcohol or drug abuse
- •current malignant disease
- •females in the fertile age (possible pregnancy or breast feeding)
- •Treatment with anticoagulants
- •BMI > 40 kg/m2
- •Dementia or cognitive dysfunction (investigators evaluation)
研究组 & 干预措施
Midodrine
Experimental
Midodrine Hydrochloride (5mg) administered as capsule 5 and 23 hours after end of surgery.
干预措施: Midodrine (Drug)
Placebo
Placebo Comparator
Placebo administered as capsule 5- and 23 hours after end of surgery.
干预措施: Placebo (Drug)
结局指标
主要结局
Orthostatic hypotension
时间窗: 6 hours after surgery
Orthostatic hypotension (OH) during early mobilization 6 hours after end of surgery. OH is classified according to international consensus.
次要结局
- Orthostatic hypotension 24 hours after surgery(24 hours after end of surgery.)
- Orthostatic Intolerance(6 and 24 hours after end of surgery)
- Treatment side effects(6 and 24 hours after end of surgery)
研究者
Oeivind Jans
M.D, Research Fellow
Rigshospitalet, Denmark
研究点 (3)
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