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

High Altitude Pulmonary Edema Clinical Trial

Official title:

A Prospective, Double-blind, Randomized, Placebo-controlled Trial of Acetazolamide on Subclinical High-Altitude Pulmonary Edema Detected by Lung Ultrasonography

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03490916
• Other study ID #: H00014860
• Status: Terminated
• Phase: Phase 4
• Start date: March 23, 2018
• Est. completion date: April 4, 2018

Study information

• Verified date: April 2019
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: April 4, 2018
• Est. primary completion date: April 4, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Altitude Sickness
• Edema
• High Altitude Pulmonary Edema
• Hypertension, Pulmonary
• Pulmonary Edema

Intervention

Drug:
• Acetazolamide
Administration of Acetazolamide
• Placebo
Administration of Placebo

Locations

Country	Name	City	State
United States	UMass Medical School	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Vincent Kan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulmonary Edema Before and After Taking Acetazolamide	Edema measured through ultrasound exam	1 month
Secondary	Time to Completion of Ultrasound Exams	Time it takes to complete ultrasound exams	1 month