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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03490916
Recruitment Status : Terminated (PI was unable to continue to gather data during the trip during to medical illness)
First Posted : April 6, 2018
Results First Posted : May 10, 2019
Last Update Posted : May 10, 2019
Sponsor:
Information provided by (Responsible Party):
Vincent Kan, University of Massachusetts, Worcester

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.

Condition or disease Intervention/treatment Phase
High Altitude Pulmonary Edema Drug: Acetazolamide Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective, Double-blind, Randomized, Placebo-controlled Trial of Acetazolamide on Subclinical High-Altitude Pulmonary Edema Detected by Lung Ultrasonography
Actual Study Start Date : March 23, 2018
Actual Primary Completion Date : April 4, 2018
Actual Study Completion Date : April 4, 2018


Arm Intervention/treatment
Experimental: Acetazolamide normal dose
One (1) dose of 250mg of Acetazolamide
Drug: Acetazolamide
Administration of Acetazolamide
Other Name: diamox

Placebo Comparator: Placebo
One (1) dose of placebo
Drug: Placebo
Administration of Placebo




Primary Outcome Measures :
  1. Pulmonary Edema Before and After Taking Acetazolamide [ Time Frame: 1 month ]
    Edema measured through ultrasound exam


Secondary Outcome Measures :
  1. Time to Completion of Ultrasound Exams [ Time Frame: 1 month ]
    Time it takes to complete ultrasound exams



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03490916


Locations
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United States, Massachusetts
UMass Medical School
Worcester, Massachusetts, United States, 01655
Sponsors and Collaborators
Vincent Kan
Investigators
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Principal Investigator: Hillary Irons, MD, PhD University of Massachusetts, Worcester
  Study Documents (Full-Text)

Documents provided by Vincent Kan, University of Massachusetts, Worcester:

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Responsible Party: Vincent Kan, Former Fellow, Department of Emergency Medicine, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT03490916    
Other Study ID Numbers: H00014860
First Posted: April 6, 2018    Key Record Dates
Results First Posted: May 10, 2019
Last Update Posted: May 10, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No ipd to share.

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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
Keywords provided by Vincent Kan, University of Massachusetts, Worcester:
Acetazolamide
High-altitude illness
High-altitude pulmonary edema
Lung comets
Lung ultrasound
Subclinical high-altitude pulmonary edema
Additional relevant MeSH terms:
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Altitude Sickness
Pulmonary Edema
Hypertension, Pulmonary
Edema
Signs and Symptoms
Respiration Disorders
Respiratory Tract Diseases
Lung Diseases
Acetazolamide
Anticonvulsants
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Diuretics
Natriuretic Agents
Physiological Effects of Drugs