HyponatremiaIronmanNCT02263586
Influence of Triathlon on the Electrolyte Balance
An observational study of Hyponatremia, run by University Hospital of Cologne at 1 site in Germany.
Trial summary
Aim of the study is examining the incidence of the occurrence of hyponatremia during a Triathlon Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyponatremia
- What is being tested?
- Education in nutrition
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,089 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2014to May 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Participants of a long-distance triathlon
Who may be able to join
- finisher of a long-distance triathlon
- > 18 years
- < 60 years
Who cannot join
- not finished a long-distance triathlon
- < 18 years
- > 60 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acid-base and Electrolyte Balance Among Triathletes in the Ironman European Championship
Aim of the study is examining the incidence of the occurrence of hyponatremia during a Triathlon
Read the detailed description
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.
- Conditions
- Hyponatremia
- Being tested
- Education in nutrition
- Keywords
- Ironman, Triathlon
- Medical subject headings
- Hyponatremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education in nutritionBehavioural
Athletes were given a 45 min lesson on the proper diet and fluid intake to prevent hyponatremia in long-distance triathlon.
What is being measured
The primary outcome is the main question the study is designed to answer.
Electrolyte balance Blood sodium
Measured: within 20 minutes after finishing the race
Secondary outcomes (1)
Acid balance
Measured: within 20 minutes after finishing the race
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2014 (estimated)
- Study startAug 2014
- Primary completionApr 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HyponatremiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,089 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of Cologne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. med. Stefan Braunecker, University Hospital of Cologne
- Investigators
- Stefan Braunecker, M.D., Principal investigator, University Hospital of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02263586
- Sponsor's protocol ID
- Ironman
- Acronym
- Ironman
- Status last verified
- May 2015
- First submitted
- 4 Oct 2014
- Last updated
- 5 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 15829535
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acid-base and Electrolyte Balance Among Triathletes in the Ironman European Championship
- ClinicalTrials.gov ID
- NCT02263586
- Acronym / sponsor ID
- Ironman / Ironman
- Conditions
- Hyponatremia
- Keywords
- Ironman, Triathlon
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,089 participants (actual)
- Lead sponsor
- University Hospital of CologneUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 13 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aim of the study is examining the incidence of the occurrence of hyponatremia during a Triathlon
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Participants of a long-distance triathlon
Key inclusion criteria (3 listed)
- finisher of a long-distance triathlon
- > 18 years
- < 60 years
Key exclusion criteria (3 listed)
- not finished a long-distance triathlon
- < 18 years
- > 60 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education in nutritionAthletes were given a 45 min lesson on the proper diet and fluid intake to prevent hyponatremia in long-distance triathlon. | Behavioural | – |
Primary outcome
Electrolyte balance Blood sodium
Time frame: within 20 minutes after finishing the race
1 secondary outcome
Acid balance
Time frame: within 20 minutes after finishing the race
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2015.
- Results publication: PubMed 15829535Almond 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan Braunecker, M.D. principal investigator
University Hospital of Cologne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyponatremia, run by University Hospital of Cologne at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electrolyte balance Blood sodium (time frame: within 20 minutes after finishing the race). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02263586, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2015.