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

W

Western States Endurance Run Research Foundation

Status

Unknown

Conditions

Exercise-associated Hyponatremia

Treatments

Other: Intravenous hypertonic Saline
Other: Oral hypertonic saline

Study type

Interventional

Funder types

Other

Identifiers

NCT01110655
WSER 2009

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • consenting Western States 100 race finisher
  • hyponatremic

Exclusion criteria

  • altered mental status

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

100 participants in 2 patient groups

Intravenous hypertonic saline
Experimental group
Treatment:
Other: Intravenous hypertonic Saline
Oral hypertonic saline
Experimental group
Treatment:
Other: Oral hypertonic saline

Trial contacts and locations

1

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Central trial contact

Bethan E Owen, BM; Martin D Hoffman, MD

Data sourced from clinicaltrials.gov

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