Acetazolamide for the Prevention of High Altitude Illness: a Comparison of Dosing
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Number of Participants With Acute Mountain Sickness as Measured by the Lake Louise Score
研究概览
简要总结
This is a phase 4, randomized, double-blinded interventional trial comparing alternative doses of Acetazolamide for the prevention of High Altitude Illness.
详细描述
Acetazolamide, or Diamox, is the standard medical prophylaxis agent for high altitude illness. The medication is effective in preventing acute mountain sickness (AMS), high altitude pulmonary edema (HAPE), and high altitude cerebral edema (HACE). Its mechanism is via inhibition of the carbonic anhydrase enzyme which counteracts the respiratory alkalosis which occurs during ascent to altitude. It facilitates the excretion of bicarbonate in the urine. As a result, acetazolamide hastens acclimatization and helps prevent high altitude disorders.
Current recommended dosing is 125 mg, orally twice daily, started 24 hours prior to ascending in elevation. Side effects include tingling of the fingers and toes and perioral numbness which may be erroneously interpreted as stroke symptoms. Since acetazolamide is a mild diuretic, frequent micturition may occur leading to interruption of daytime activities as well as broken sleep. These effects can affect safety at high altitude. Acetazolamide is normally discontinued 2 days after the user has reached their highest elevation or a plateau in elevation.
A lower dose may be just as effective in preventing high altitude illnesses while preventing the disconcerting side effects resulting from its use. A smaller dose has not been studied, however. We will compare the common dose of 125 mg twice daily with a lower dose of 62.5 mg twice daily.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years or older
- •English or Indian speaking
- •Mountaineers or trekkers who plan to climb Mt. McKinley or trek to Base Camp on Mt. Everest
排除标准
- •Low sodium and/potassium blood serum levels
- •Kidney disease or dysfunction
- •Liver disease, dysfunction, or cirrhosis
- •Suprarenal gland failure or dysfunction
- •Hyperchloremic acidosis
- •Angle-closure glaucoma
- •Taking high dose aspirin (over 325 mg/day)
- •Any reaction to sulfa drugs or acetazolamide
- •Pregnant or lactating women
研究组 & 干预措施
Acetazolamide normal dose
Experimental : Acetazolamide 125 mg twice daily
干预措施: Normal Dose Acetazolamide (Drug)
Acetazolamide low dose
Experimental: Acetazolamide 62.5 mg twice daily
干预措施: Low Dose Acetazolamide (Drug)
结局指标
主要结局
Number of Participants With Acute Mountain Sickness as Measured by the Lake Louise Score
时间窗: 12 days
Lake Louise Score, A total score of 3 to 5 indicates mild AMS. A score of 6 or more signifies severe AMS. Minimum value - 0, Maximum = 15
次要结局
- Number of Participants With Side Effects(12 days)
研究者
Scott McIntosh
Associate Professor
University of Utah
