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

• Sponsor: Vincent Kan (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03490916
• Collaborator: (none)
• Enrollment: 18
• Location: 1
• Arms: 2
• Actual Duration (Days): 12
• Patients Per Site Per Month: 45.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
High Altitude Pulmonary Edema	Drug: Acetazolamide; Drug: Placebo	Phase 4

Study Design

• Study Type: Interventional
• 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: Mar 23, 2018
• Actual Primary Completion Date: Apr 4, 2018
• Actual Study Completion Date: Apr 4, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Pulmonary Edema Before and After Taking Acetazolamide [1 month]

   Edema measured through ultrasound exam

Secondary Outcome Measures

1. Time to Completion of Ultrasound Exams [1 month]

   Time it takes to complete ultrasound exams

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UMass Medical School	Worcester	Massachusetts	United States	01655

Sponsors and Collaborators

• Vincent Kan

Investigators

• Principal Investigator: Hillary Irons, MD, PhD, University of Massachusetts, Worcester

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 14, 2018

More Information

Publications

None provided.

• 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: Apr 6, 2018
• Last Update Posted: May 10, 2019
• Last Verified: Apr 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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, Former Fellow, Department of Emergency Medicine, 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: Altitude Sickness; Pulmonary Edema; Hypertension, Pulmonary; Edema; Acetazolamide

Study Results

Participant Flow

Arm/Group Title	Acetazolamide Normal Dose	Placebo
Arm/Group Description	One (1) dose of 250mg of Acetazolamide Acetazolamide: Administration of Acetazolamide	One (1) dose of placebo Placebo: Administration of Placebo
Period Title: Overall Study
STARTED	0	0
COMPLETED	0	0
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Acetazolamide Normal Dose	Placebo	Total
Arm/Group Description	One (1) dose of 250mg of Acetazolamide Acetazolamide: Administration of Acetazolamide	One (1) dose of placebo Placebo: Administration of Placebo	Total of all reporting groups
Overall Participants	0	0	0
Age () []
<=18 years
Between 18 and 65 years
>=65 years
Age () []
Sex: Female, Male () []
Female
Male
Ethnicity (NIH/OMB) () []
Hispanic or Latino
Not Hispanic or Latino
Unknown or Not Reported
Race (NIH/OMB) () []
American Indian or Alaska Native
Asian
Native Hawaiian or Other Pacific Islander
Black or African American
White
More than one race
Unknown or Not Reported
Region of Enrollment (participants) []

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

No participants were randomized and no participants received intervention.

Arm/Group Title	Acetazolamide Normal Dose	Placebo
Arm/Group Description	One (1) dose of 250mg of Acetazolamide Acetazolamide: Administration of Acetazolamide	One (1) dose of placebo Placebo: Administration of Placebo
Measure Participants	0	0

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Participants enrolled but not randomized and did not receive study drug.

Arm/Group Title	Acetazolamide Normal Dose	Placebo
Arm/Group Description	One (1) dose of 250mg of Acetazolamide Acetazolamide: Administration of Acetazolamide	One (1) dose of placebo Placebo: Administration of Placebo
Measure Participants	0	0

Adverse Events

Time Frame	Due to investigator illness, no participants were randomized and no study drug was administered.
Adverse Event Reporting Description	Due to investigator illness, no participants were randomized and no study drug was administered.
Arm/Group Title	Acetazolamide Normal Dose		Placebo
Arm/Group Description	One (1) dose of 250mg of Acetazolamide Acetazolamide: Administration of Acetazolamide		One (1) dose of placebo Placebo: Administration of Placebo
All Cause Mortality
	Acetazolamide Normal Dose		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Serious Adverse Events
	Acetazolamide Normal Dose		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Acetazolamide Normal Dose		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

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

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.