<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/NCT02263586</url>
  </required_header>
  <id_info>
    <org_study_id>Ironman</org_study_id>
    <nct_id>NCT02263586</nct_id>
  </id_info>
  <brief_title>Influence of Triathlon on the Electrolyte Balance</brief_title>
  <acronym>Ironman</acronym>
  <official_title>Acid-base and Electrolyte Balance Among Triathletes in the Ironman European Championship</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital of Cologne</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital of Cologne</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Aim of the study is examining the incidence of the occurrence of hyponatremia during a&#xD;
      Triathlon&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Studies in similar endurance sports (e.g. marathon) could already indicate a high incidence&#xD;
      for the appearance of hyponatremia during competitions. The loss of sodium through sweating&#xD;
      and the excessive fluid intake during the competitions is a primary risk factor for the&#xD;
      development of hyponatremia.&#xD;
&#xD;
      Based on the known occurrence of hyponatremia in marathon runners, participants of the&#xD;
      Ironman European Championship between the years 2005 and 2014 were screened for the&#xD;
      occurrence of hyponatremia after finishing the race for safety reasons. Subjects were&#xD;
      approached at random in the athlete's garden and invited to participate. All participants&#xD;
      were 18 years or older.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">May 2015</completion_date>
  <primary_completion_date type="Actual">April 2015</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Electrolyte balance Blood sodium</measure>
    <time_frame>within 20 minutes after finishing the race</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Acid balance</measure>
    <time_frame>within 20 minutes after finishing the race</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">1089</enrollment>
  <condition>Hyponatremia</condition>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Education in nutrition</intervention_name>
    <description>Athletes were given a 45 min lesson on the proper diet and fluid intake to prevent hyponatremia in long-distance triathlon.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Participants of a long-distance triathlon&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  finisher of a long-distance triathlon&#xD;
&#xD;
          -  &gt; 18 years&#xD;
&#xD;
          -  &lt; 60 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  not finished a long-distance triathlon&#xD;
&#xD;
          -  &lt; 18 years&#xD;
&#xD;
          -  &gt; 60 years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stefan Braunecker, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Cologne</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Uniklinik Köln</name>
      <address>
        <city>Köln</city>
        <state>NRW</state>
        <zip>50937</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <results_reference>
    <citation>Almond CS, Shin AY, Fortescue EB, Mannix RC, Wypij D, Binstadt BA, Duncan CN, Olson DP, Salerno AE, Newburger JW, Greenes DS. Hyponatremia among runners in the Boston Marathon. N Engl J Med. 2005 Apr 14;352(15):1550-6. doi: 10.1056/NEJMoa043901.</citation>
    <PMID>15829535</PMID>
  </results_reference>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>October 4, 2014</study_first_submitted>
  <study_first_submitted_qc>October 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 13, 2014</study_first_posted>
  <last_update_submitted>May 2, 2015</last_update_submitted>
  <last_update_submitted_qc>May 2, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 5, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital of Cologne</investigator_affiliation>
    <investigator_full_name>Dr. med. Stefan Braunecker</investigator_full_name>
    <investigator_title>Anesthesiologist, Researcher</investigator_title>
  </responsible_party>
  <keyword>Ironman</keyword>
  <keyword>Triathlon</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyponatremia</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/NCT02263586
org study id: Ironman
nct id: NCT02263586
lead sponsor: 
has dmc: No
Aim of the study is examining the incidence of the occurrence of hyponatremia during a
      Triathlon
Studies in similar endurance sports (e.g. marathon) could already indicate a high incidence
      for the appearance of hyponatremia during competitions. The loss of sodium through sweating
      and the excessive fluid intake during the competitions is a primary risk factor for the
      development of hyponatremia.

      Based on the known occurrence of hyponatremia in marathon runners, participants of the
      Ironman European Championship between the years 2005 and 2014 were screened for the
      occurrence of hyponatremia after finishing the race for safety reasons. Subjects were
      approached at random in the athlete's garden and invited to participate. All participants
      were 18 years or older.
observational model: Cohort
time perspective: Retrospective
measure: Electrolyte balance Blood sodium
time frame: within 20 minutes after finishing the race
measure: Acid balance
time frame: within 20 minutes after finishing the race
intervention type: Behavioral
intervention name: Education in nutrition
description: Athletes were given a 45 min lesson on the proper diet and fluid intake to prevent hyponatremia in long-distance triathlon.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Stefan Braunecker, M.D.
role: Principal Investigator
affiliation: University Hospital Cologne
facility: 
country: Germany
citation: Almond CS, Shin AY, Fortescue EB, Mannix RC, Wypij D, Binstadt BA, Duncan CN, Olson DP, Salerno AE, Newburger JW, Greenes DS. Hyponatremia among runners in the Boston Marathon. N Engl J Med. 2005 Apr 14;352(15):1550-6. doi: 10.1056/NEJMoa043901.
PMID: 15829535
responsible party type: Principal Investigator
investigator affiliation: University Hospital of Cologne
investigator full name: Dr. med. Stefan Braunecker
investigator title: Anesthesiologist, Researcher
mesh term: Hyponatremia