Erythropoietin in the Prevention of Acute Mountain Sickness

Acute Mountain Sickness Clinical Trial

— EPO-AMS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01665781
• Other study ID #: AMCIRB2012-0534
• Status: Completed
• Phase: Phase 4
• First received: August 12, 2012
• Last updated: March 16, 2013
• Start date: August 2012
• Est. completion date: March 2013

Study information

• Verified date: March 2013
• Source: University of Ulsan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Healthy adults

Exclusion Criteria:

• History of serious illness

• Current smoker or Hemoglobin >15.5gm/dL

• Uncontrolled hypertension

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Mountain Sickness
• Altitude Sickness

Intervention

Drug:
• Erythropoietin

Locations

Country	Name	City	State
Korea, Republic of	Soon Bae Kim, M.D., Ph.D.	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
University of Ulsan	CJ HealthCare Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute mountain sickness score	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.	At 3230m and 4,130m(Annapurna base camp)	Yes
Secondary	Criteria for immediate descent[USARIEM]	High altitude cerebral edema 1) Mental confusion 2) Ataxia 3) Severe lassitude; 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; Severe AMS: LLS >8	At 3230m and 4,130m(Annapurna base camp)	Yes