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临床试验/NCT03424226
NCT03424226已完成1 期

Sickness Evaluation at Altitude With Acetazolamide at Relative Dosages

Stanford University1 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2018年8月4日最近更新:
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
105
试验地点
1
主要终点
incidence of acute mountain sickness

研究概览

简要总结

This double blind randomized trial will compare acetazolamide taken the morning of ascent to acetazolamide taken the evening prior to ascent for the prevention of acute mountain sickness (AMS). The day of ascent dosing has not been studied as a powered primary outcome. The study population is hikers who are ascending at their own rate under their own power in a true hiking environment at the White Mountain Research Station, Owen Valley Lab (OVL) and Bancroft Station (BAR), Bancroft Peak, White Mountain, California

详细描述

The specific aim of this study is to determine whether acetazolamide started the day-of ascent is inferior to the standard night before ascent dose of acetazolamide for the prevention of acute mountain sickness (AMS) in travelers in travelers to high altitude. Acetazolamide has been examined in over 200 high altitude studies over the past 50 years, and is the most commonly used drug for AMS prevention in the high mountains of Nepal, Western Europe, and Africa. Current Wilderness Medical Society Practice Guidelines recommend a 125mg dose of acetazolamide daily started the day or evening prior to ascent. However, day of ascent dosage has recently been found to be effective prophylaxis for severe AMS compared to placebo, but efficacy of day-of ascent dosage has not be confirmed versus standard acetazolamide dosage.

While acetazolamide is commonly used as an acclimatization aid, it is traditionally started the day or evening prior to ascent to theoretically optimize diuretic effect and compensatory respiratory changes. This timing may be impractical when rapid ascent is necessary, such as in search and rescue and military operations, or for the general recreationalists, trekkers, or climbers who do not have time to start prophylaxis prior to heading into the mountains. As there are an estimated 100 million recreationalists annually who ascend to high altitude around the world, innovation on optimal timing has a potentially large impact on traveler safety.

Acetazolamide has a time of onset between 60 - 90 minutes when taken as an immediate release tablet, with peak effect between 2 - 4 hours. With these pharmacokinetics in mind, we recently found that there was an observed robust protective effect of acetazolamide on severe AMS when taken the morning of ascent, and this was the first study to examine day-of dosing. This novel finding has not been otherwise investigated, and confirmation of this unique observation has the potential to increase acetazolamide'sits usage in "high risk" populations maximizing safety, while minimizing discomfort and poor sleep from pre-ascent nocturia., such as trekkers, skiers, climbers, and tactical missions requiring rapid ascents in the mountains of North America and Europe.

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)

盲法说明

Visually identical pills

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18-75 healthy non-pregnant volunteer
  • live at low elevation < 4000 ft
  • Arrange your own transportation to WMRS (Bishop) by Friday evening of study weekend
  • Available for full study duration (Friday PM-Sunday AM)

排除标准

  • Age <18 or >75, Pregnant, Live at altitude >4000 ft Slept at altitude > 4000ft within 1 week of study Allergic to acetazolamide, sulfa drugs, Taking non-steroidal anti-inflammatory drugs, Acetazolamide, or Corticosteroids 1 week prior to study

研究组 & 干预措施

day of acetazolamide

Experimental

acetazolamide 125mg twice a day, started morning of ascent

干预措施: Acetazolamide (Drug)

night before acetazolamide

Active Comparator

acetazolamide 125mg twice a day, started evening before ascent

干预措施: Acetazolamide (Drug)

结局指标

主要结局

incidence of acute mountain sickness

时间窗: 2 days

incidence of acute mountain sickness by Lake Louise Questionnaire

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Grant S Lipman

Associate Professor Department of Emergency Medicine, Stanford University

Stanford University

研究点 (1)

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