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

NCT ID: NCT01110655

Last Updated: 2010-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2010-06-30

Brief Summary

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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

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Conditions

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Exercise-associated Hyponatremia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intravenous hypertonic saline

Group Type EXPERIMENTAL

Intravenous hypertonic Saline

Intervention Type OTHER

Intravenous 100mL bolus of 3% saline

Oral hypertonic saline

Group Type EXPERIMENTAL

Oral hypertonic saline

Intervention Type OTHER

Oral 100mL bolus of 3% saline

Interventions

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Intravenous hypertonic Saline

Intravenous 100mL bolus of 3% saline

Intervention Type OTHER

Oral hypertonic saline

Oral 100mL bolus of 3% saline

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* consenting Western States 100 race finisher
* hyponatremic

Exclusion Criteria

* altered mental status
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Western States Endurance Run Research Foundation

OTHER

Sponsor Role lead

Responsible Party

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Western States Endurance Run

Principal Investigators

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Martin D Hoffman, MD

Role: STUDY_CHAIR

Western States Endurance Run Foundation

Locations

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Western States Endurance Run

Sacramento, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Martin D Hoffman, MD

Role: CONTACT

(916) 843-9027

Bethan E Owen, BM

Role: CONTACT

Facility Contacts

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Martin D Hofman, MD

Role: primary

916-843-9027

Bethan E Owen, BM

Role: backup

Other Identifiers

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WSER 2009

Identifier Type: -

Identifier Source: org_study_id

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