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Sickness Evaluation at Altitude With Acetazolamide at Relative Dosages (SEAWARD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03424226
Recruitment Status : Completed
First Posted : February 6, 2018
Last Update Posted : November 20, 2018
Sponsor:
Information provided by (Responsible Party):
Grant S Lipman, Stanford University

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Acute Mountain Sickness Drug: Acetazolamide Phase 1

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double blind randomized controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Visually identical pills
Primary Purpose: Prevention
Official Title: Sickness Evaluation at Altitude With Acetazolamide at Relative Dosages
Actual Study Start Date : August 4, 2018
Actual Primary Completion Date : September 30, 2018
Actual Study Completion Date : September 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: day of acetazolamide
acetazolamide 125mg twice a day, started morning of ascent
Drug: Acetazolamide
a diuretic and commonly used medication for prevention and treatment of acute mountain sickness
Other Name: diamox

Active Comparator: night before acetazolamide
acetazolamide 125mg twice a day, started evening before ascent
Drug: Acetazolamide
a diuretic and commonly used medication for prevention and treatment of acute mountain sickness
Other Name: diamox




Primary Outcome Measures :
  1. incidence of acute mountain sickness [ Time Frame: 2 days ]
    incidence of acute mountain sickness by Lake Louise Questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03424226


Locations
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United States, California
Stanford University
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
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Responsible Party: Grant S Lipman, Associate Professor Department of Emergency Medicine, Stanford University, Stanford University
ClinicalTrials.gov Identifier: NCT03424226    
Other Study ID Numbers: 44765
First Posted: February 6, 2018    Key Record Dates
Last Update Posted: November 20, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Altitude Sickness
Respiration Disorders
Respiratory Tract Diseases
Acetazolamide
Anticonvulsants
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Diuretics
Natriuretic Agents
Physiological Effects of Drugs