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Erythropoietin in the Prevention of Acute Mountain Sickness

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Sponsorii
University of Ulsan
Colaboratori
HK inno.N Corporation

Cuvinte cheie

Abstract

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.

Datele

Ultima verificare: 02/28/2013
Primul depus: 08/11/2012
Inscriere estimată trimisă: 08/13/2012
Prima postare: 08/14/2012
Ultima actualizare trimisă: 03/15/2013
Ultima actualizare postată: 03/18/2013
Data actuală de începere a studiului: 07/31/2012
Data estimată de finalizare primară: 02/28/2013
Data estimată de finalizare a studiului: 02/28/2013

Stare sau boală

Acute Mountain Sickness

Intervenție / tratament

Drug: Erythropoietin

Fază

Fază 4

Grupuri de brațe

BraţIntervenție / tratament
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

Criterii de eligibilitate

Vârste eligibile pentru studiu 18 Years La 18 Years
Sexe eligibile pentru studiuAll
Acceptă voluntari sănătoșida
Criterii

Inclusion Criteria:

- Healthy adults

Exclusion Criteria:

- History of serious illness

- Current smoker or Hemoglobin >15.5gm/dL

- Uncontrolled hypertension

Rezultat

Măsuri de rezultate primare

1. Acute mountain sickness score [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.

Măsuri de rezultate secundare

1. Criteria for immediate descent[USARIEM] [At 3230m and 4,130m(Annapurna base camp)]

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

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