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

April 23, 2010 updated by: Western States Endurance Run Research Foundation

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95835
        • Recruiting
        • Western States Endurance Run
        • Contact:
        • Contact:
        • Principal Investigator:
          • Tamara Hew-Butler, DPM, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • consenting Western States 100 race finisher
  • hyponatremic

Exclusion Criteria:

  • altered mental status

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intravenous hypertonic saline
Other: Intravenous hypertonic Saline
Intravenous 100mL bolus of 3% saline
EXPERIMENTAL: Oral hypertonic saline
Other: Oral hypertonic saline
Oral 100mL bolus of 3% saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Blood sodium concentration post administration of oral or IV hypertonic saline.
Time Frame: 1 hour post administration of hypertonic saline
1 hour post administration of hypertonic saline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Western States Endurance Run Research Foundation

Investigators

  • Study Chair: Martin D Hoffman, MD, Western States Endurance Run Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (ANTICIPATED)

June 1, 2010

Study Completion (ANTICIPATED)

June 1, 2010

Study Registration Dates

First Submitted

April 23, 2010

First Submitted That Met QC Criteria

April 23, 2010

First Posted (ESTIMATE)

April 26, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

April 26, 2010

Last Update Submitted That Met QC Criteria

April 23, 2010

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WSER 2009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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