Effect of acetazolamide on the frequency of high altitude pulmonary edema at 4559 m

Phase 1

• Conditions: Healthy volunteer trial at 4459m to investigate the effect of acetazolamide on the incidence of high altitude pulmonary edema.; MedDRA version: 20.0Level: LLTClassification code 10020045Term: High altitude illnessSystem Organ Class: 100000004863; Therapeutic area: Body processes [G] - Physical Phenomena [G01]

• Registration Number: EUCTR2017-005166-22-AT
• Lead Sponsor: K für Anästhesiologie und allgemeine Intensivmedizin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-02-07
• Study Completion: 2019-08-08
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

- Age 18-64 years
- Previous history of high altitude pulmonary edema
- Good physical condition
- No relevant pathologies upon the pre-examination prior to the study
- Written informed consent to participate in the study
- Permanent residency below 1000 m
- Males and females are included without prioritization
- Previous experience in the use of crampons and ice axe
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Acute and chronic lung diseases
- Conventional systolic blood pressure (average of two measurements) =150 mmHg and conventional diastolic blood pressure =95 mmHg in untreated or treated subjects
- Cardiovascular diseases other than systemic arterial hypertension (coronary heart disease, pulmonary hypertension, heart failure, atrial fibrillation, peripheral artery disease)
- Chronic headache / migraine
- Diabetes mellitus
- Smoking (>6 cigarettes/day) or equivalent nicotine substitutes
- Alcohol (>30 g/d) or drug abuse
- Obesity (Body Mass Index >30)
- Other conditions deemed relevant by the investigator (including liver disease, renal disease, thyroid disorders, pregnancy, lactation)
- Sojourn >2000 m within the last 4 weeks before the 1st study day
- Drug intake within the last 2 moth before the 1st study day if the drug intake could affect the data quality (eg. corticosteroids) or the safety of the participants (eg. anti-coagulants)
- Hypersensitivity to acetazolamide, sulfonamides, or any component of the formulation
- Blood donation within the last 2 month before the 1st study da

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Does acetazolamide reduce the incidence of high altitude pulmoanry edema after rapid and active ascent to 4559 m?;Secondary Objective: 1. Does acetazolamide reduce the height of pulmonary artery pressure after rapid, active ascent to 4559 m?<br>2. Does acetazolamide reduce the incidence of acute mountain sickness after rapid, active ascent to 4559 m?<br>;Primary end point(s): Incidence of high altitude pulmonary edema;Timepoint(s) of evaluation of this end point: After 72 hours at 4559 m

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Height of pulmonary artery systolic pressure<br>2. Incidence of acute mountain sickness;Timepoint(s) of evaluation of this end point: After 72 hours at 4559 m