Clinical Trial: Erythropoietin in the Prevention of Acute Mountain Sickness

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Randomized, Controlled Trial of Erythropoietin in the Prevention of Acute Mountain Sickness

Brief Summary:

Acute mountain sickness (AMS) is a syndrome of nonspecific symptoms and is therefore subjective. The Lake Louise Consensus Group defined acute mountain sickness as the presence of headache in an unacclimatized person who has recently arrived at an altitude above 2,500 m plus the presence of one or more of the following: gastrointestinal symptoms (anorexia, nausea, or vomiting), insomnia, dizziness, and lassitude or fatigue. An increase in RBC mass is a natural feature of altitude acclimatization. Hypoxia-induced erythropoietin (EPO) secretion begins hours after ascent and stimulates bone marrow production of red blood cells, but this takes weeks to effect an increase in red cell mass . Therefore, it is feasible that EPO therapy weeks before altitude exposure decrease high altitude illness.

In 1996, Young et al in U.S. Army Research Institute of Environmental Medicine (USARIEM) reported that autologous erythrocyte infusion did not ameliorate the decrement in maximal oxygen uptake at 4,300m altitude despite increasing arterial oxygen carrying capacity. On the basis of this report, USARIEM did not recommend use of recombinant EPO for altitude acclimatization.

However, increases in erythrocyte count, hematocrit and hemoglobin associated with EPO therapy have been shown to decrease fatigue and increase work capacity and exercise tolerance. In addition, improvement in CNS function and cognitive ability has been noted with EPO therapy. Subjective benefits include improvement in sleep habits, tolerance to cold; decreased dyspnea, anginal symptoms and tachycardia and improved appetite, all of which are symptoms associated with high altitude illness.

The investigators also reported improved muscle energy metabolism with EPO in dialysis patients, but not with RBC transfusion.

Detailed Summary:
Sponsor: University of Ulsan

Current Primary Outcome: Acute mountain sickness score [ Time Frame: At 3230m and 4,130m(Annapurna base camp) ]

The AMS self-report score is the sum of answers to five questions (headache; gastrointestinal symptoms (anorexia, nausea, or vomiting); fatigue or weakness; dizziness or lightheadedness; difficulty sleeping) rating from 0 to 3.


Original Primary Outcome: Acute mountain sickness score [ Time Frame: 120min ]

The AMS self-report score is the sum of answers to five questions (headache; gastrointestinal symptoms (anorexia, nausea, or vomiting); fatigue or weakness; dizziness or lightheadedness; difficulty sleeping) rating from 0 to 3.


Current Secondary Outcome: Criteria for immediate descent[USARIEM] [ Time Frame: At 3230m and 4,130m(Annapurna base camp) ]

  1. High altitude cerebral edema 1) Mental confusion 2) Ataxia 3) Severe lassitude
  2. Moderate high altitude pulmonary edema 1) Symptoms of dyspnea, weakness, fatigue with mild exertion 2) Cannot perform light activity 3) Headache with cough, dyspnea at rest 4) Heartbeats per min: 110-120 5) Breaths per min: 20-30
  3. Severe AMS: LLS >8


Original Secondary Outcome: Criteria for immediate descent [ Time Frame: 120min ]

Evidence of HAPE or HACE


Information By: University of Ulsan

Dates:
Date Received: August 12, 2012
Date Started: August 2012
Date Completion:
Last Updated: March 16, 2013
Last Verified: March 2013