Back to results

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

Primary Purpose

Exercise-associated Hyponatremia

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Intravenous hypertonic Saline

Oral hypertonic saline

About this trial

This is an interventional treatment trial for Exercise-associated Hyponatremia focused on measuring Exercise-associated hyponatremia, Randomized treatment trial, Endurance runners

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

consenting Western States 100 race finisher
hyponatremic

Exclusion Criteria:

altered mental status

Sites / Locations

Western States Endurance RunRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Intravenous hypertonic saline

Oral hypertonic saline

Arm Description

Outcomes

Primary Outcome Measures

Blood sodium concentration post administration of oral or IV hypertonic saline.

Secondary Outcome Measures

Full Information

NCT ID

NCT01110655

First Posted

April 23, 2010

Last Updated

April 23, 2010

Sponsor

Western States Endurance Run Research Foundation

1. Study Identification

Unique Protocol Identification Number

NCT01110655

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2010

Overall Recruitment Status

Unknown status

Study Start Date

June 2009 (undefined)

Primary Completion Date

June 2010 (Anticipated)

Study Completion Date

June 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Western States Endurance Run Research Foundation

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Exercise-associated Hyponatremia

Keywords

Exercise-associated hyponatremia, Randomized treatment trial, Endurance runners

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intravenous hypertonic saline

Arm Type

Experimental

Arm Title

Oral hypertonic saline

Arm Type

Experimental

Intervention Type

Other

Intervention Name(s)

Intravenous hypertonic Saline

Intervention Description

Intravenous 100mL bolus of 3% saline

Intervention Type

Other

Intervention Name(s)

Oral hypertonic saline

Intervention Description

Oral 100mL bolus of 3% saline

Primary Outcome Measure Information:

Title

Blood sodium concentration post administration of oral or IV hypertonic saline.

Time Frame

1 hour post administration of hypertonic saline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: consenting Western States 100 race finisher hyponatremic Exclusion Criteria: altered mental status

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Martin D Hoffman, MD

Phone

(916) 843-9027

martin.hoffman@va.gov

First Name & Middle Initial & Last Name or Official Title & Degree

Bethan E Owen, BM

bethanelin@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Martin D Hoffman, MD

Organizational Affiliation

Western States Endurance Run Foundation

Official's Role

Study Chair

Facility Information:

Facility Name

Western States Endurance Run

City

Sacramento

State/Province

California

ZIP/Postal Code

95835

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Martin D Hofman, MD

Phone

916-843-9027

martin.hoffman@va.gov

First Name & Middle Initial & Last Name & Degree

Bethan E Owen, BM

bethanelin@yahoo.com

First Name & Middle Initial & Last Name & Degree

Tamara Hew-Butler, DPM, PhD

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs