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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous hypertonic saline | Experimental |
| |
| Oral hypertonic saline | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous hypertonic Saline | Other | Intravenous 100mL bolus of 3% saline |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Blood sodium concentration post administration of oral or IV hypertonic saline. | 1 hour post administration of hypertonic saline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Martin D Hoffman, MD | Contact | (916) 843-9027 | martin.hoffman@va.gov | |
| Bethan E Owen, BM | Contact | bethanelin@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Martin D Hoffman, MD | Western States Endurance Run Foundation | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Western States Endurance Run | Recruiting | Sacramento | California | 95835 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 1, 2015 | |
| Reset | Jun 17, 2015 | |
| Release | Dec 8, 2015 |
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| Oral hypertonic saline |
| Other |
Oral 100mL bolus of 3% saline |
|
| Reset | Jan 8, 2016 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 1, 2015 | Jun 17, 2015 | |||
| Dec 8, 2015 | Jan 8, 2016 |
| ID | Term |
|---|---|
| D012462 | Saline Solution, Hypertonic |
| ID | Term |
|---|---|
| D006982 | Hypertonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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