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

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

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.

Study Overview

• Status: Terminated
• Conditions: High Altitude Pulmonary Edema
• Intervention / Treatment: Drug: Acetazolamide; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Worcester, Massachusetts, United States, 01655
      • UMass Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Acetazolamide normal dose; One (1) dose of 250mg of Acetazolamide	Drug: Acetazolamide; Administration of Acetazolamide; Other Names: diamox
PLACEBO_COMPARATOR: Placebo; One (1) dose of placebo	Drug: Placebo; Administration of Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulmonary Edema Before and After Taking Acetazolamide	Edema measured through ultrasound exam	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Completion of Ultrasound Exams	Time it takes to complete ultrasound exams	1 month

Collaborators and Investigators

• Sponsor: Vincent Kan
• Investigators: Principal Investigator: Hillary Irons, MD, PhD, University of Massachusetts, Worcester

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 23, 2018
• Primary Completion (ACTUAL): April 4, 2018
• Study Completion (ACTUAL): April 4, 2018

Study Registration Dates

• First Submitted: March 30, 2018
• First Submitted That Met QC Criteria: March 30, 2018
• First Posted (ACTUAL): April 6, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 10, 2019
• Last Update Submitted That Met QC Criteria: April 18, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Acetazolamide; Lung ultrasound; High-altitude illness; High-altitude pulmonary edema; Lung comets; Subclinical high-altitude pulmonary edema
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Hypertension; Altitude Sickness; Hypertension, Pulmonary; Edema; Pulmonary Edema; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Carbonic Anhydrase Inhibitors; Natriuretic Agents; Diuretics; Anticonvulsants; Acetazolamide
• Other Study ID Numbers: H00014860

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No ipd to share.

Drug and device information, study documents

• 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