Back to resultsEffect of Acetazolamide on Subclinical High-Altitude Pulmonary Edema Detected by Lung Ultrasonography
Primary Purpose
High Altitude Pulmonary Edema
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Acetazolamide
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for High Altitude Pulmonary Edema focused on measuring Acetazolamide, High-altitude illness, High-altitude pulmonary edema, Lung comets, Lung ultrasound, Subclinical high-altitude pulmonary edema
Eligibility Criteria
Inclusion Criteria:
- At least 18 years of age
- Able to consent
- English speaking
- Trekking directly to Everest Base Camp
Exclusion Criteria:
- Age less than 18 years
- Non-English speaking
- Pregnant
- Already had a diagnosis of acute mountain sickness, high-altitude cerebral edema, or high-altitude pulmonary edema
- Been on a high-altitude trek 2 weeks prior to this study
- Has taken acetazolamide 1 week prior to start of trek
- Has a sulfa allergy
- Has any type of acute or chronic pulmonary conditions
Sites / Locations
- UMass Medical School
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Acetazolamide normal dose
Placebo
Arm Description
One (1) dose of 250mg of Acetazolamide
One (1) dose of placebo
Outcomes
Primary Outcome Measures
Pulmonary Edema Before and After Taking Acetazolamide
Edema measured through ultrasound exam
Secondary Outcome Measures
Time to Completion of Ultrasound Exams
Time it takes to complete ultrasound exams
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03490916
Brief Title
Effect of Acetazolamide on Subclinical High-Altitude Pulmonary Edema Detected by Lung Ultrasonography
Official Title
A Prospective, Double-blind, Randomized, Placebo-controlled Trial of Acetazolamide on Subclinical High-Altitude Pulmonary Edema Detected by Lung Ultrasonography
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Terminated
Why Stopped
PI was unable to continue to gather data during the trip during to medical illness
Study Start Date
March 23, 2018 (Actual)
Primary Completion Date
April 4, 2018 (Actual)
Study Completion Date
April 4, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Vincent Kan
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High Altitude Pulmonary Edema
Keywords
Acetazolamide, High-altitude illness, High-altitude pulmonary edema, Lung comets, Lung ultrasound, Subclinical high-altitude pulmonary edema
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Acetazolamide normal dose
Arm Type
Experimental
Arm Description
One (1) dose of 250mg of Acetazolamide
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
One (1) dose of placebo
Intervention Type
Drug
Intervention Name(s)
Acetazolamide
Other Intervention Name(s)
diamox
Intervention Description
Administration of Acetazolamide
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administration of Placebo
Primary Outcome Measure Information:
Title
Pulmonary Edema Before and After Taking Acetazolamide
Description
Edema measured through ultrasound exam
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Time to Completion of Ultrasound Exams
Description
Time it takes to complete ultrasound exams
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
At least 18 years of age
Able to consent
English speaking
Trekking directly to Everest Base Camp
Exclusion Criteria:
Age less than 18 years
Non-English speaking
Pregnant
Already had a diagnosis of acute mountain sickness, high-altitude cerebral edema, or high-altitude pulmonary edema
Been on a high-altitude trek 2 weeks prior to this study
Has taken acetazolamide 1 week prior to start of trek
Has a sulfa allergy
Has any type of acute or chronic pulmonary conditions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hillary Irons, MD, PhD
Organizational Affiliation
University of Massachusetts, Worcester
Official's Role
Principal Investigator
Facility Information:
Facility Name
UMass Medical School
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No ipd to share.
Learn more about this trial
Effect of Acetazolamide on Subclinical High-Altitude Pulmonary Edema Detected by Lung Ultrasonography
We'll reach out to this number within 24 hrs