High Altitude Pulmonary Edema
Conditions
Keywords
Acetazolamide, High-altitude illness, High-altitude pulmonary edema, Lung comets, Lung ultrasound, Subclinical high-altitude pulmonary edema
Brief summary
The overall goal of this study is to detect preclinical signs of HAPE by lung ultrasonography and evaluate the effectiveness of acetazolamide at decreasing pulmonary edema by using ultrasound.
Interventions
DRUGAcetazolamide
Administration of Acetazolamide
DRUGPlacebo
Administration of Placebo
Sponsors
Vincent Kan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. At least 18 years of age 2. Able to consent 3. English speaking 4. Trekking directly to Everest Base Camp
Exclusion criteria
1. Age less than 18 years 2. Non-English speaking 3. Pregnant 4. Already had a diagnosis of acute mountain sickness, high-altitude cerebral edema, or high-altitude pulmonary edema 5. Been on a high-altitude trek 2 weeks prior to this study 6. Has taken acetazolamide 1 week prior to start of trek 7. Has a sulfa allergy 8. Has any type of acute or chronic pulmonary conditions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pulmonary Edema Before and After Taking Acetazolamide | 1 month | Edema measured through ultrasound exam |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Completion of Ultrasound Exams | 1 month | Time it takes to complete ultrasound exams |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Acetazolamide Normal Dose One (1) dose of 250mg of Acetazolamide
Acetazolamide: Administration of Acetazolamide | 0 |
| Placebo One (1) dose of placebo
Placebo: Administration of Placebo | 0 |
| Total | 0 |
Baseline characteristics
| Characteristic | — |
|---|---|
| Region of Enrollment United States | — participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Pulmonary Edema Before and After Taking Acetazolamide
Edema measured through ultrasound exam
Time frame: 1 month
Population: No participants were randomized and no participants received intervention.
Secondary
Time to Completion of Ultrasound Exams
Time it takes to complete ultrasound exams
Time frame: 1 month
Population: Participants enrolled but not randomized and did not receive study drug.