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

August 12, 2012
March 16, 2013
August 2012
March 2013   (final data collection date for primary outcome measure)
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.
Acute mountain sickness score [ Time Frame: 120min ] [ 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.
Complete list of historical versions of study NCT01665781 on ClinicalTrials.gov Archive Site
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
Criteria for immediate descent [ Time Frame: 120min ] [ Designated as safety issue: Yes ]
Evidence of HAPE or HACE
Not Provided
Not Provided
 
Erythropoietin in the Prevention of Acute Mountain Sickness
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Acute Mountain Sickness
Drug: Erythropoietin
  • Experimental: Erythropoietin
    Erythropoietin 10,000U, weekly, for 4 weeks Last dose: 1 week before departure (10days before high altitude)
    Intervention: Drug: Erythropoietin
  • No Intervention: Control
    No erythropoietin
Heo K, Kang JK, Choi CM, Lee MS, Noh KW, Kim SB. Prophylactic effect of erythropoietin injection to prevent acute mountain sickness: an open-label randomized controlled trial. J Korean Med Sci. 2014 Mar;29(3):416-22. doi: 10.3346/jkms.2014.29.3.416. Epub 2014 Feb 27.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
39
March 2013
March 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy adults

Exclusion Criteria:

  • History of serious illness
  • Current smoker or Hemoglobin >15.5gm/dL
  • Uncontrolled hypertension
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01665781
AMCIRB2012-0534
Yes
Soon Bae Kim, M.D., PhD., University of Ulsan
University of Ulsan
CJ HealthCare Corporation
Principal Investigator: Soon Bae Kim, M.D., Ph.D. University of Ulsan
University of Ulsan
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP