The Efficacy of Oral Versus Intravenous Hypertonic Saline Administration in Runners With Exercise-Associated Hyponatremia
The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Western States Endurance Run Research Foundation.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Western States Endurance Run Research Foundation
Information provided by:
Western States Endurance Run Research Foundation
ClinicalTrials.gov Identifier:
NCT01110655
First received: April 23, 2010
Last updated: NA
Last verified: April 2010
History: No changes posted
| Tracking Information | |||||||||
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| First Received Date ICMJE | April 23, 2010 | ||||||||
| Last Updated Date | April 23, 2010 | ||||||||
| Start Date ICMJE | June 2009 | ||||||||
| Estimated Primary Completion Date | June 2010 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Blood sodium concentration post administration of oral or IV hypertonic saline. [ Time Frame: 1 hour post administration of hypertonic saline ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | The Efficacy of Oral Versus Intravenous Hypertonic Saline Administration in Runners With Exercise-Associated Hyponatremia | ||||||||
| Official Title ICMJE | Incidence and Cause of Hyponatremia in Endurance Runners, Also to Determine if Oral Hypertonic Saline is as Efficacious as Intravenous Hypertonic Saline in the Correction of Below Normal Blood Sodium Concentrations in Runners With Hyponatremia Without Neurological Symptoms | ||||||||
| Brief Summary | The purpose of the study is to 1) evaluate incidence and primary cause of exercise-associated Hyponatremia (EAH) in race finishers participating in the Western States 100-mile Endurance Run, 2) determine if the ingestion of oral hypertonic saline (high salt) is as effective as intravenous administration of hypertonic saline to elevate below-normal blood salt concentrations (EAH) at the end of the Western States Endurance Run, and 3) determine if oral and intravenous hypertonic saline solutions are equally as effective at reversing mild (without altered mental status) symptoms associated with EAH. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Exercise-associated Hyponatremia | ||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 100 | ||||||||
| Estimated Completion Date | June 2010 | ||||||||
| Estimated Primary Completion Date | June 2010 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01110655 | ||||||||
| Other Study ID Numbers ICMJE | WSER 2009 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Martin D. Hoffman, MD, Western States Endurance Run | ||||||||
| Study Sponsor ICMJE | Western States Endurance Run Research Foundation | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Western States Endurance Run Research Foundation | ||||||||
| Verification Date | April 2010 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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