A Study Comparing Treatment with Oral Solution versus the Standard Intravenous Fluid Therapy for Acute Dehydration in Adults

Overview

About this study

The purpose of this study is to compare the efficiency and patient acceptability of treatment with an oral rehydration solution versus the standard intravenous fluid therapy used for acute dehydration in an adult emergency department setting.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

  • Males or females between the ages of 18 and 70 years
  • Must have a diagnosis of mild to moderate dehydration not associated with migraine headache or diabetic ketoacidosis
  • Must be free of any disease condition, which in the judgment of the investigator or designee would interfere with the evaluations in the study or impair the patient’s safe participation in the study
  • Must be capable of understanding the study and providing informed consent

Exclusion Criteria

  • History or evidence of any disease or condition, which in the opinion of the investigator or designee adversely affects the study evaluations or the safety of the patient’s participation in the study
  • Any patient for whom the investigator or designee anticipates the possible need for hospitalization
  • Any patient who may require I.V. therapy for purposes other than hydration
  • Has evidence of migraine contributing to dehydration
  • Has dehydration from diabetes mellitus and/or ketoacidosis
  • Any history or evidence of congestive heart failure (NYHA ≥ II)
  • Any history or evidence of chronic kidney disease (GFR < <60 mL/min/1.73 m2 for at least 3 months)
  • Any history or evidence of edema or fluid accumulation syndromes
  • Inability to comprehend the study procedures or to understand and sign the Informed Consent
  • Any fluid or electrolyte restrictions
  • Evidence of significant drug addiction or active use of any drug of abuse
  • Intoxicated or evidence of excessive alcohol use
  • A history of intolerance or allergy to any of the hydration fluids or other substances used in this study
  • A history of allergy or intolerance to Ondansetron
  • Currently Pregnant or Nursing
  • Evidence suggesting a perforated or obstructed bowel upon examination by the treating clinician
  • Prisoners

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

James Homme, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Additional contact information

Non-cancer trials contact form

Phone: 800-664-4542 (toll-free)

International patient clinical studies questions