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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01110655
Recruitment Status : Unknown
Verified April 2010 by Western States Endurance Run Research Foundation.
Recruitment status was:  Recruiting
First Posted : April 26, 2010
Last Update Posted : April 26, 2010
Sponsor:
Information provided by:
Western States Endurance Run Research Foundation

Tracking Information
First Submitted Date  ICMJE April 23, 2010
First Posted Date  ICMJE April 26, 2010
Last Update Posted Date April 26, 2010
Study Start Date  ICMJE June 2009
Estimated Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 23, 2010)
Blood sodium concentration post administration of oral or IV hypertonic saline. [ Time Frame: 1 hour post administration of hypertonic saline ]
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 Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Exercise-associated Hyponatremia
Intervention  ICMJE
  • Other: Intravenous hypertonic Saline
    Intravenous 100mL bolus of 3% saline
  • Other: Oral hypertonic saline
    Oral 100mL bolus of 3% saline
Study Arms  ICMJE
  • Experimental: Intravenous hypertonic saline
    Intervention: Other: Intravenous hypertonic Saline
  • Experimental: Oral hypertonic saline
    Intervention: Other: Oral hypertonic saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 23, 2010)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2010
Estimated Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • consenting Western States 100 race finisher
  • hyponatremic

Exclusion Criteria:

  • altered mental status
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01110655
Other Study ID Numbers  ICMJE WSER 2009
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
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
Study Chair: Martin D Hoffman, MD Western States Endurance Run Foundation
PRS Account Western States Endurance Run Research Foundation
Verification Date April 2010

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