Pedialyte or Gatorade for Viral Gastroenteritis in Adults: a Randomized, Controlled Trial

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

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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Background: Pedialyte and Gatorade are advocated for the treatment of dehydration in viral gastroenteritis, but there is limited evidence to support their use.

Objective: To examine the efficacy, safety and palatability of Pedialyte, Gatorade, and a New Oral Rehydration Solution (NS).

Design: Randomized double blind. Setting: Inpatient, community hospital. Patients/Interventions: 75 consecutive adult patients (m/f=44/33) admitted with viral gastroenteritis were randomized to receive Gatorade, Pedialyte or NS for 48 hours. A yogurt/rice diet was allowed ad libitum.

Measurements: Stool and urine output, electrolytes, fluid intake, body weight, hematocrit and palatability of solutions.

Limitations: Smaller sample size and higher drop out (20%).

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Detailed Description

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Conditions

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Gastroenteritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Gatorade, Pedialyte and New Solution

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects were included if they had mild-to-moderate diarrhea, with mildly sunken eyes and a clinical assessment of dehydration of less than 5%, a serum sodium concentration between 130-150 mEq/L, adequate general health and nutrition, a BUN/creatinine ratio of \>20 and with a normal pulse rate for age and degree of fever and adequate skin turgor

Exclusion Criteria

* Patients were excluded if they had hyperthermia (\>39.0º C), serum sodium \>150 mEq/L or \<130 mEq/L, white cell count \>15,000, bloody diarrhea (dysentery), abnormal cardiovascular or renal function or an underlying metabolic or nutritional disorder and most importantly, if the clinical assessment of dehydration was \>7% that suggested a need for intravenous fluids.

Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No