The SPironolactone and ACEtazolamide (SPACE) trial in the prevention of acute mountain sickness

Completed

• Conditions: Acute mountain sickness; Signs and Symptoms; acute mountain sickness

• Registration Number: ISRCTN77054547
• Lead Sponsor: niversity of Oxford (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09-04
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 300

Inclusion Criteria

1. Healthy subjects between the ages of 18 and 65
2. Male or female
3. Non-Nepali
4. Without AMS or any concurrent illness
5. Not already taking acetazolamide or any other drug for the prevention of altitude illness

Subjects will be enrolled by study administrators en route directly to Everest Base Camp or Kala Patthar between the villages of Pheriche/Dingboche and Lobuje.

Exclusion Criteria

1. Individuals not meeting inclusion criteria, including mild AMS (more than one mild symptom on the Lake Louise Questionnaire) or significantly depressed oxygen saturation (less than 75%)
2. Females known to be pregnant, or cannot exclude the possibility of being pregnant, or have missed menses by over seven days
3. Individuals with a known drug allergy to acetazolamide or other sulfa drugs
4. Individuals who are on Angiotensin-Converting Enzyme (ACE) inhibitors (like enalapril) or other diuretics like amiloride or triamterene, as concurrent administration with spironolactone can cause hyperkalemia
5. Individuals who have spent 24 hours at an altitude of 4500 metres/14,000 feet within the last nine days
6. Anyone known to have taken any of the following in the last two days:
6.1. Acetazolamide (Diamox®)
6.2. Steroids (dexamethasone, prednisone)
6.3. Theophylline
6.4. Diuretics (Lasix®)
7. Individuals who have a known intracranial space occupying lesion or a history of elevated intracranial pressure, (i.e. tumours, hydrocephalus, etc)
8. Lack of informed consent will obviously mandate exclusion

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main outcome measure will be incidence of AMS measured by Lake Louise acute mountain sickness score (LLscore) greater than or equal to three with headache and at least one other symptom.<br><br>Outcomes will be measured at baseline (Pheriche 4300 m) and remeasured at Lobuje (5000 m). The reassessment will take place at least 36 hours to a maximum of 96 hours (four days) after taking the study drug.

Secondary Outcome Measures

Name	Time	Method
1. Oxygen saturation measured by pulse oximeter<br>2. Severity of symptom (LLscore greater than five)<br>3. Incidence of headache and severity of headache<br><br>Outcomes will be measured at baseline (Pheriche 4300 m) and remeasured at Lobuje (5000 m). The reassessment will take place at least 36 hours to a maximum of 96 hours (four days) after taking the study drug.