Effect of Acetazolamide on Subclinical High-Altitude Pulmonary Edema Detected by Lung Ultrasonography

Phase 4

Terminated

• Conditions: High Altitude Pulmonary Edema
• Interventions: Drug: Acetazolamide; Drug: Placebo

• Registration Number: NCT03490916
• Lead Sponsor: Vincent Kan

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-23
• Study First Submitted: 2018-03-30
• Study First Submitted QC: 2018-03-30
• Primary Completion: 2018-04-04
• Study Completion: 2018-04-04
• Study First Posted: 2018-04-06
• Status Verified: 2019-04
• Results First Submitted: 2019-04-18
• Results First Submitted QC: 2019-04-18
• Last Update Submitted: 2019-04-18
• Results First Posted: 2019-05-10
• Last Update Posted: 2019-05-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acetazolamide normal dose	Acetazolamide	One (1) dose of 250mg of Acetazolamide
Placebo	Placebo	One (1) dose of placebo

Primary Outcome Measures

Name	Time	Method
Pulmonary Edema Before and After Taking Acetazolamide	1 month	Edema measured through ultrasound exam

Secondary Outcome Measures

Name	Time	Method
Time to Completion of Ultrasound Exams	1 month	Time it takes to complete ultrasound exams

Trial Locations

Locations (1)

UMass Medical School; 🇺🇸 Worcester, Massachusetts, United States