The Efficacy of Oral Versus Intravenous Hypertonic Saline Administration in Runners With Exercise-Associated Hyponatremia

Exercise-associated Hyponatremia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01110655
• Other study ID #: WSER 2009
• Status: Unknown status
• Phase: N/A
• First received: April 23, 2010
• Last updated: April 23, 2010
• Start date: June 2009
• Est. completion date: June 2010

Study information

• Verified date: April 2010
• Source: Western States Endurance Run Research Foundation
• Contact: Martin D Hoffman, MD
• Phone: (916) 843-9027
• Email: martin.hoffman[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 100
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• consenting Western States 100 race finisher

• hyponatremic

Exclusion Criteria:

• altered mental status

Related Conditions & MeSH terms

• Exercise-associated Hyponatremia
• Hyponatremia

Intervention

Other:
• Intravenous hypertonic Saline
Intravenous 100mL bolus of 3% saline
• Oral hypertonic saline
Oral 100mL bolus of 3% saline

Locations

Country	Name	City	State
United States	Western States Endurance Run	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
Western States Endurance Run Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood sodium concentration post administration of oral or IV hypertonic saline.		1 hour post administration of hypertonic saline