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

NCT03490916 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: H00014860
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

High Altitude Pulmonary Edema

Keywords

Acetazolamide; High-altitude illness; High-altitude pulmonary edema; Lung comets; Lung ultrasound; Subclinical high-altitude pulmonary edema

Outcome Measures

Primary Outcomes (1)

• Pulmonary Edema Before and After Taking Acetazolamide

  Edema measured through ultrasound exam

  1 month

Secondary Outcomes (1)

• Time to Completion of Ultrasound Exams

  1 month

Study Arms (2)

Acetazolamide normal dose

EXPERIMENTAL

One (1) dose of 250mg of Acetazolamide

Drug: Acetazolamide

Placebo

PLACEBO COMPARATOR

One (1) dose of placebo

Drug: Placebo

Interventions

Acetazolamide DRUG

Administration of Acetazolamide

Also known as: diamox

Acetazolamide normal dose

Placebo DRUG

Administration of Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age
• Able to consent
• English speaking
• Trekking directly to Everest Base Camp

You may not qualify if:

• 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

Sponsors & Collaborators

• Vincent Kan: lead

Study Sites (1)

UMass Medical School

Worcester, Massachusetts, 01655, United States

Location

MeSH Terms

Conditions

Altitude Sickness

Interventions

Acetazolamide

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Thiadiazoles; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

Due to Investigator illness, although participants were enrolled, no participants were randomized to receive interventions and did not receive study drug.

Results Point of Contact

• Title: Principal Investigator
• Organization: UMass Medical School

vincent.kan08@gmail.com

4136279111

Study Officials

• Hillary Irons, MD, PhD

  University of Massachusetts, Worcester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Former Fellow, Department of Emergency Medicine

Study Record Dates

• First Submitted: March 30, 2018
• First Posted: April 6, 2018
• Study Start: March 23, 2018
• Primary Completion: April 4, 2018
• Study Completion: April 4, 2018
• Last Updated: May 10, 2019
• Results First Posted: May 10, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)