The SPironolactone and ACEtazolamide (SPACE) trial in the prevention of acute mountain sickness
| ISRCTN | ISRCTN77054547 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN77054547 |
| Secondary identifying numbers | OXTREC 1 |
- Submission date
- 30/07/2007
- Registration date
- 04/09/2007
- Last edited
- 24/11/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Buddha Basnyat
Scientific
Scientific
Nepal International Clinic
Lal Durbar
GPO BOX 3596
Kathmandu
1
Nepal
| rishibas@wlink.com.np |
Study information
| Study design | Randomised, double blind, placebo controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study acronym | SPACE |
| Study objectives | Acute Mountain Sickness (AMS) is like a hangover (headache, nausea and tiredness being prominent features) that may manifest at altitudes greater than 2600 m when people ascend too high too fast. This is a study to ascertain the benefit of spironolactone (aldactone), a water pill, in the prevention of AMS which comprises of headache, nausea and tiredness at altitude greater than 2700 m. Acetazolamide (Diamox®) which we know works for the prevention of AMS will be compared with spironolactone and a placebo or a sugar pill. Hypothesis: Spironolactone will prevent AMS. |
| Ethics approval(s) | Added 24/11/2008: OXTREC approval on 07/10/2008 for the study (031 07). |
| Health condition(s) or problem(s) studied | Acute mountain sickness |
| Intervention | This is a prospective three armed, double blind, randomised, placebo controlled trial. Computer generated randomisation of spironolatone, acetazolamide and placebo will be carried out. After consent is obtained, participants will receive a four days supply of either spironolactone 50 mg twice daily (bid), acetazolamide 250 mg bid or visually matched placebo bid. Trekkers will be enrolled in the study and baseline measurements done at Pheriche (4300 m) and reassessed after their arrival at the endpoint in Lobuje (5000 m). The reassessment will take place at least 36 hours to a maximum of 96 hours (4 days) after taking the study drug. Assessments and measurements will be made in these areas prior to and after ascension on the study drug: 1. Lake Louise Questionnaire 2. Oxygen saturation via pulse oximetry The approach to Everest Base Camp provides a unique study population for the following reasons: 1. Large numbers of recently arrived (non-acclimated) trekkers 2. Relatively homogenous population (gender, age, physical fitness, etc.) with relatively few pre-existing conditions 3. Linear population movement along the approach 4. Rapid and quantitatively large elevation change (about 700 m) Data will also be collected on the demographics of the study population at the enrolment site. The study will not provide financial assistance in the event of the development of complications of being at high altitude. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Spironolactone, acetazolamide |
| Primary outcome measure | 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. 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 | 1. Oxygen saturation measured by pulse oximeter 2. Severity of symptom (LLscore greater than five) 3. Incidence of headache and severity of headache 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. |
| Overall study start date | 10/10/2007 |
| Completion date | 25/11/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target number of participants | 100 in each arm of the study |
| Key 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. |
| Key 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 |
| Date of first enrolment | 10/10/2007 |
| Date of final enrolment | 25/11/2007 |
Locations
Countries of recruitment
- Nepal
Study participating centre
Nepal International Clinic
Kathmandu
1
Nepal
1
Nepal
Sponsor information
University of Oxford (UK)
University/education
University/education
University Offices
Wellington Square
Oxford
0X1 2JD
United Kingdom
| Phone | +44 (0)1865 270143 |
|---|---|
| research.services@admin.ox.ac.uk | |
| Website | http://www.ox.ac.uk/ |
"ROR" |
https://ror.org/052gg0110 |
Funders
Funder type
Research organisation
Oxford University Clinical Research Unit (Vietnam) (ref: HB0075)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
