<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01698619</url>
  </required_header>
  <id_info>
    <org_study_id>AconcaguaIron</org_study_id>
    <nct_id>NCT01698619</nct_id>
  </id_info>
  <brief_title>Hemodynamic Changes in Altitude Adaptation</brief_title>
  <official_title>Hemodynamic Changes in Altitude Adaptation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Goethe University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Goethe University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      We use a new technology (Nexfin from BMEYE-Inventive Hemodynamics) to monitor Cardiac Output,&#xD;
      Blood Pressure, Fluid Responsiveness, Pulse Oximetry, Hemoglobin Concentration, Oxygen&#xD;
      Delivery in Climbers during their process of acclimatization on a expedition to Mount&#xD;
      Aconcagua.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Several parameters will be recorded to analyze their influence on the adaptation to high&#xD;
      altitude. Such as, food composition, dietary supplements, water intake and output.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2012</start_date>
  <completion_date type="Anticipated">December 2012</completion_date>
  <primary_completion_date type="Anticipated">December 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Changes from baseline in Oxygen Delivery</measure>
    <time_frame>daily, up to 18 days</time_frame>
    <description>Unit: ml/min baseline measure will be obtained at sea level</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in Hemoglobin Concentration</measure>
    <time_frame>daily, up to 18 days</time_frame>
    <description>Unit: mg/dl baseline measure will be obtained at sea level</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Changes from baseline in Blood pressure, Fluid Responsiveness, Oxygen Saturation, Cardiac Output</measure>
    <time_frame>daily, up to 18 days</time_frame>
    <description>baseline measure will be obtained at sea level</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">12</enrollment>
  <condition>Acute Mountain Sickness</condition>
  <condition>High Altitude Pulmonary Edema</condition>
  <condition>High Altitude Cerebral Edema</condition>
  <arm_group>
    <arm_group_label>Climbers on Mount Aconcagua</arm_group_label>
    <description>The Cohort consists of volunteers climbing Mount Aconcagua.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        healthy volunteers taking part in an expedition to Mount Aconcagua&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  No acute or chronic disease&#xD;
&#xD;
          -  Body mass index : 20 - 30&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any preexisting disease that has a potential impact on physical performance such as:&#xD;
&#xD;
               -  pulmonary&#xD;
&#xD;
               -  cerebral&#xD;
&#xD;
               -  muscular&#xD;
&#xD;
               -  cardiac&#xD;
&#xD;
               -  vascular - diseases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Goethe University</name>
      <address>
        <city>Frankfurt</city>
        <state>Hessen</state>
        <zip>60590</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Peter Stein, Dr.</last_name>
      <phone>0049 1577 6400 769</phone>
      <email>peter.stein@kgu.de</email>
    </contact>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 27, 2012</study_first_submitted>
  <study_first_submitted_qc>October 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2012</study_first_posted>
  <last_update_submitted>October 2, 2012</last_update_submitted>
  <last_update_submitted_qc>October 2, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 3, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Goethe University</investigator_affiliation>
    <investigator_full_name>Peter Stein</investigator_full_name>
    <investigator_title>Consultant</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Altitude Sickness</mesh_term>
    <mesh_term>Pulmonary Edema</mesh_term>
    <mesh_term>Brain Edema</mesh_term>
    <mesh_term>Edema</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01698619
org study id: AconcaguaIron
nct id: NCT01698619
lead sponsor: 
has dmc: No
We use a new technology (Nexfin from BMEYE-Inventive Hemodynamics) to monitor Cardiac Output,
      Blood Pressure, Fluid Responsiveness, Pulse Oximetry, Hemoglobin Concentration, Oxygen
      Delivery in Climbers during their process of acclimatization on a expedition to Mount
      Aconcagua.
Several parameters will be recorded to analyze their influence on the adaptation to high
      altitude. Such as, food composition, dietary supplements, water intake and output.
observational model: Cohort
time perspective: Prospective
measure: Changes from baseline in Oxygen Delivery
time frame: daily, up to 18 days
description: Unit: ml/min baseline measure will be obtained at sea level
measure: Changes from baseline in Hemoglobin Concentration
time frame: daily, up to 18 days
description: Unit: mg/dl baseline measure will be obtained at sea level
measure: Changes from baseline in Blood pressure, Fluid Responsiveness, Oxygen Saturation, Cardiac Output
time frame: daily, up to 18 days
description: baseline measure will be obtained at sea level
arm group label: Climbers on Mount Aconcagua
description: The Cohort consists of volunteers climbing Mount Aconcagua.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
status: Recruiting
contact: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Goethe University
investigator full name: Peter Stein
investigator title: Consultant
mesh term: Altitude Sickness
mesh term: Pulmonary Edema
mesh term: Brain Edema
mesh term: Edema