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

Primary Purpose

Acute Mountain Sickness

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Erythropoietin
Sponsored by
University of Ulsan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Mountain Sickness focused on measuring Hemoglobin, Erythropoietin, Acute Mountain sickness

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy adults

Exclusion Criteria:

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

Sites / Locations

  • Soon Bae Kim, M.D., Ph.D.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Erythropoietin

Control

Arm Description

Erythropoietin 10,000U, weekly, for 4 weeks Last dose: 1 week before departure (10days before high altitude)

No erythropoietin

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
August 12, 2012
Last Updated
March 16, 2013
Sponsor
University of Ulsan
Collaborators
HK inno.N Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01665781
Brief Title
Erythropoietin in the Prevention of Acute Mountain Sickness
Acronym
EPO-AMS
Official Title
Randomized, Controlled Trial of Erythropoietin in the Prevention of Acute Mountain Sickness
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Ulsan
Collaborators
HK inno.N Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Mountain Sickness
Keywords
Hemoglobin, Erythropoietin, Acute Mountain sickness

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Erythropoietin
Arm Type
Experimental
Arm Description
Erythropoietin 10,000U, weekly, for 4 weeks Last dose: 1 week before departure (10days before high altitude)
Arm Title
Control
Arm Type
No Intervention
Arm Description
No erythropoietin
Intervention Type
Drug
Intervention Name(s)
Erythropoietin
Primary Outcome Measure Information:
Title
Acute mountain sickness score
Description
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.
Time Frame
At 3230m and 4,130m(Annapurna base camp)
Secondary Outcome Measure Information:
Title
Criteria for immediate descent[USARIEM]
Description
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
Time Frame
At 3230m and 4,130m(Annapurna base camp)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy adults Exclusion Criteria: History of serious illness Current smoker or Hemoglobin >15.5gm/dL Uncontrolled hypertension
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Soon Bae Kim, M.D., Ph.D.
Organizational Affiliation
University of Ulsan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Soon Bae Kim, M.D., Ph.D.
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
24616593
Citation
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.
Results Reference
derived

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Erythropoietin in the Prevention of Acute Mountain Sickness

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