Randomized, placebo controlled trial evaluating the effect of acetazolamide on lung water content by ultrasound in lowlanders older than 40 years travelling from 760 m to 3'100 m.
This is a randomized, placebo-controlled, double-blind parallel trial evaluating the effect of preventive acetazolamide intake on lung water content by ultrasound in lowlanders older than 40 years travelling to altitude. Participants living in the Bishkek area, Kyrgyzstan (760m), will be transferred by car within 4h to the Tuja Ashu high altitude clinic (3'100 m), and stay there for 2 days. Acetazolamide 375mg/day (or placebo), will be administered before departure at 760 m and during the stay at altitude. Outcomes will be assessed during the stay at 3'100 m. An interim analysis will be carried out when 200 participants will have completed the study and/or after the first year. The Peto's method will be used and the trial will be stopped when pre-specified futility boundaries were crossed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
100
Administration of 1x125mg acetazolamide in the morning, 2x125mg in the evening, starting 24 hours before departure to 3'100m
Administration of equally looking placebo capsules in the morning and evening, starting 24 hours before departure to 3'100m
National Center of Cardiology and Internal Medicine
Bishkek, Kyrgyzstan
ultrasound lung comets
Difference in altitude-induced change of ultrasound lung comets between acetazolamide and placebo
Time frame: Day 2 at 760m and 3100m
ultrasound lung comets
Difference in ultrasound lung comets between acetazolamide and placebo
Time frame: Day 2 at 3100m
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