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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01665781
Recruitment Status : Completed
First Posted : August 15, 2012
Last Update Posted : March 19, 2013
Sponsor:
Collaborator:
HK inno.N Corporation
Information provided by (Responsible Party):
Soon Bae Kim, M.D., PhD., University of Ulsan

Tracking Information
First Submitted Date  ICMJE August 12, 2012
First Posted Date  ICMJE August 15, 2012
Last Update Posted Date March 19, 2013
Study Start Date  ICMJE August 2012
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 16, 2013)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 14, 2012)
Acute mountain sickness score [ Time Frame: 120min ]
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 16, 2013)
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
Original Secondary Outcome Measures  ICMJE
 (submitted: August 14, 2012)
Criteria for immediate descent [ Time Frame: 120min ]
Evidence of HAPE or HACE
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Erythropoietin in the Prevention of Acute Mountain Sickness
Official Title  ICMJE Randomized, Controlled Trial of Erythropoietin in the Prevention of Acute Mountain Sickness
Brief 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Acute Mountain Sickness
Intervention  ICMJE Drug: Erythropoietin
Study Arms  ICMJE
  • 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
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 16, 2013)
39
Original Estimated Enrollment  ICMJE
 (submitted: August 14, 2012)
40
Actual Study Completion Date  ICMJE March 2013
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy adults

Exclusion Criteria:

  • History of serious illness
  • Current smoker or Hemoglobin >15.5gm/dL
  • Uncontrolled hypertension
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01665781
Other Study ID Numbers  ICMJE AMCIRB2012-0534
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Soon Bae Kim, M.D., PhD., University of Ulsan
Study Sponsor  ICMJE University of Ulsan
Collaborators  ICMJE HK inno.N Corporation
Investigators  ICMJE
Principal Investigator: Soon Bae Kim, M.D., Ph.D. University of Ulsan
PRS Account University of Ulsan
Verification Date March 2013

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