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
Sponsor:
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

April 23, 2010
April 23, 2010
June 2009
June 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
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The Efficacy of Oral Versus Intravenous Hypertonic Saline Administration in Runners With Exercise-Associated Hyponatremia
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

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Exercise-associated Hyponatremia
  • Other: Intravenous hypertonic Saline
    Intravenous 100mL bolus of 3% saline
  • Other: Oral hypertonic saline
    Oral 100mL bolus of 3% saline
  • Experimental: Intravenous hypertonic saline
    Intervention: Other: Intravenous hypertonic Saline
  • Experimental: Oral hypertonic saline
    Intervention: Other: Oral hypertonic saline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
June 2010
June 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • consenting Western States 100 race finisher
  • hyponatremic

Exclusion Criteria:

  • altered mental status
Both
18 Years and older
Yes
Contact: Martin D Hoffman, MD (916) 843-9027 martin.hoffman@va.gov
Contact: Bethan E Owen, BM bethanelin@yahoo.com
United States
 
NCT01110655
WSER 2009
No
Martin D. Hoffman, MD, Western States Endurance Run
Western States Endurance Run Research Foundation
Not Provided
Study Chair: Martin D Hoffman, MD Western States Endurance Run Foundation
Western States Endurance Run Research Foundation
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP