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

March 16, 2013 updated by: Soon Bae Kim, M.D., PhD., University of Ulsan

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy adults

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Erythropoietin
Erythropoietin 10,000U, weekly, for 4 weeks Last dose: 1 week before departure (10days before high altitude)
Drug: Erythropoietin
No Intervention: Control
No erythropoietin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At 3230m and 4,130m(Annapurna base camp)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At 3230m and 4,130m(Annapurna base camp)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Ulsan

Collaborators

HK inno.N Corporation

Investigators

  • Principal Investigator: Soon Bae Kim, M.D., Ph.D., University of Ulsan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

August 12, 2012

First Submitted That Met QC Criteria

August 14, 2012

First Posted (Estimate)

August 15, 2012

Study Record Updates

Last Update Posted (Estimate)

March 19, 2013

Last Update Submitted That Met QC Criteria

March 16, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMCIRB2012-0534

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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