Erythropoietin in the Prevention of Acute Mountain Sickness (EPO-AMS)

University of Ulsan

Status and phase: Completed; Phase 4

Conditions: Acute Mountain Sickness

Treatments: Drug: Erythropoietin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01665781

AMCIRB2012-0534

Details and patient eligibility

About

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.

In this study, the investigators will conduct a randomised controlled trial to assess the effect of EPO administration on AMS at an altitude of 4,130 m.

Enrollment: 39 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy adults

Exclusion criteria

• History of serious illness
• Current smoker or Hemoglobin >15.5gm/dL
• Uncontrolled hypertension

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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39 participants in 2 patient groups

Erythropoietin

Experimental group

Description:

Erythropoietin 10,000U, weekly, for 4 weeks Last dose: 1 week before departure (10days before high altitude)

Treatment:

Drug: Erythropoietin

Control

No Intervention group

Description:

No erythropoietin