A randomised double blind placebo controlled trial to ascertain the benefit of acetazolamide in the prevention of HAPE (High Altitude Pulmonary Edema)

Completed

Conditions: High altitude pulmonary edema
Respiratory

Registration Number: ISRCTN28251193

Lead Sponsor: niversity of Oxford (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 500

Inclusion Criteria

1. Healthy men or women between the ages of 18 and 65 without any current illness, travelling DIRECTLY to either Mount Everest base camp or Kala Patthar, not using any drugs for the prevention of altitude sickness.

Exclusion Criteria

1. Younger than 18 years old or 65 years or older
2. Trekkers going to Gokyo, Chukung Ri, or Island Peak BEFORE going to Kala Patthar or Everest base camp
3. Altitude sickness (more than one mild symptom on the Lake Louise Questionnaire [LLQ]) or significantly depressed oxygen saturation (less than 75%)
4. Pregnant woman or women who cannot exclude the possibility of being pregnant, or have missed menses by over seven days
5. A known drug allergy to acetazolamide or other sulfa drugs
6. Have already stayed the night at an altitude of 4500 m/14000 ft within the last nine days
7. Have taken any of the following in the last two days: acetazolamide (diamox®), steroids (dexamethasone, prednisone), theophylline, or diuretics (lasix®), viagra, nifedipine
8. Have any serious intracranial abnormalities such as history of brain tumors or pseudotumour cerebri or any known cardiac or lung disease

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Evaluation for HAPE in study participants will be made by study administrators after a minimum of 15 minutes of rest. Study administrators will have had prior experience taking vital signs and performing lung examinations. Diagnosis of a participant with or without AMS will be made only if two of the following signs and two of the following symptoms are present:<br>a. Symptoms: chest tightness, cough, dyspnea at rest, markedly decreased exercise performance (LLQ fatigue score of three)<br>b. Signs: central cyanosis, pulmonary crackles, tachycardia (more than 110 beats per minute), tachypnea (more than 25 revolutions per minute)<br>2. Doppler echocardiography will be performed also after 15 minutes of rest by trained echocardiographers. Cutoff criteria for HAPE will be the measurement of pulmonary artery systolic pressure of 48 mmHg or greater via transtricuspid pressures) with normal left ventricular wall motion and function

Secondary Outcome Measures

Name	Time	Method
1. Pulse oxygen saturation of less than 70% in subjects meeting HAPE diagnosis<br>2. The change in PAP from 4300 m to 5000 m or the delta PAP will be measured and compared between placebo and acetazolamide groups<br>3. Incidence of AMS, HAPE, and HACE in this cohort of people ascending from 4300 m to 5000 m in the Khumbu region