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

This study has been completed.
Sponsor:
Collaborator:
CJ HealthCare Corporation
Information provided by (Responsible Party):
Soon Bae Kim, M.D., PhD., University of Ulsan
ClinicalTrials.gov Identifier:
NCT01665781
First received: August 12, 2012
Last updated: March 16, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Acute Mountain Sickness
Drug: Erythropoietin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Randomized, Controlled Trial of Erythropoietin in the Prevention of Acute Mountain Sickness

Resource links provided by NLM:


Further study details as provided by University of Ulsan:

Primary Outcome Measures:
  • Acute mountain sickness score [ Time Frame: At 3230m and 4,130m(Annapurna base camp) ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Criteria for immediate descent[USARIEM] [ Time Frame: At 3230m and 4,130m(Annapurna base camp) ] [ Designated as safety issue: Yes ]
    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


Enrollment: 39
Study Start Date: August 2012
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy adults

Exclusion Criteria:

  • History of serious illness
  • Current smoker or Hemoglobin >15.5gm/dL
  • Uncontrolled hypertension
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01665781

Locations
Korea, Republic of
Soon Bae Kim, M.D., Ph.D.
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
University of Ulsan
CJ HealthCare Corporation
Investigators
Principal Investigator: Soon Bae Kim, M.D., Ph.D. University of Ulsan
  More Information

No publications provided by University of Ulsan

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Soon Bae Kim, M.D., PhD., Professor of Medicine, University of Ulsan
ClinicalTrials.gov Identifier: NCT01665781     History of Changes
Other Study ID Numbers: AMCIRB2012-0534
Study First Received: August 12, 2012
Last Updated: March 16, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by University of Ulsan:
Hemoglobin
Erythropoietin
Acute Mountain sickness

Additional relevant MeSH terms:
Altitude Sickness
Respiration Disorders
Respiratory Tract Diseases
Epoetin alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 14, 2014