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临床试验/NCT03154645
NCT03154645已完成1 期

Altitude Sickness Prevention With Ibuprofen Relative to Acetazolamide and Treatment Efficacy

Grant S Lipman1 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2017年8月12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
发起方
入组人数
92
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 ibuprofen to acetazolamide for the prevention of acute mountain sickness. These drugs have never been directly compared for efficacy. 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 evaluate if acetazolamide will be similar to ibuprofen (i.e. Ibuprofen being non-inferior) in decreasing the incidence of Acute Mountain Sickness (AMS) in travelers to high altitude. It has been shown that ibuprofen taken 3 times a day 6 hours prior to ascent is effective for the prevention of AMS, with a number needed to treat of 4, decreasing the odds of getting AMS by a third. The efficacy appears to be similar to acetazolamide, with a NNT of 3 -8, although these two medications have not been directly compared in prevention of AMS. Acetazolamide is diuretic that is the only FDA approved AMS prophylactic medication and the most commonly used drug for AMS prevention. Although acetazolamide has been given a 1A indication, it has been shown to limit exercise capabilities at high altitude, and rapid ascent has been shown to attenuate its protective effects. Ibuprofen has been given a IIB recommendation by the Wilderness Medical Society Practice Guidelines, in part because it has not directly compared to acetazolamide. It is unknown if a non-steroidal anti-inflammatory can provide protection from AMS equivalent to acetazolamide.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18-65 healthy non-pregnant volunteer
  • Sea-level dwelling (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 >65, Pregnant, Live at altitude >4000 ft
  • Slept at altitude > 4000ft within 1 week of study
  • Allergic to acetazolamide, sulfa drugs, or non-steroidal anti-inflammatories
  • Taking NSAIDs, Acetazolamide, or Corticosteroids 1 week prior to study
  • Medical History of Brain Tumor, increased brain pressure, pseudotumor cerebri, VP shunts, HACE, or HAPE.

研究组 & 干预措施

Ibuprofen

Active Comparator

ibuprofen, 600mg, three times a day, through to ascent to high altitude

干预措施: Ibuprofen (Drug)

acetazolamide

Active Comparator

acetazolamide, 125mg, two times a day, through to ascent to high altitude

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

  • severity of acute mountain sickness(2 days)
  • oxygen saturation(2 days)
  • Groningen Sleep Quality Questionnaire (GSQQ)(2 days)

研究者

发起方
Grant S Lipman
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Grant S Lipman

Principal Investigator

Stanford University

研究点 (1)

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