Pedialyte or Gatorade for Viral Gastroenteritis in Adults: a Randomized, Controlled Trial
Sponsor
Augusta University (Other)
Overall Status
Completed
CT.gov ID
NCT00257374
Collaborator
(none)
1
Study Details
Study Description
Brief Summary
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%).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Ages Eligible for Study:
19 Years
to 80 Years
Sexes Eligible for Study:
All
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 (>39.0ยบ 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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Dept. of Gastroenterology & Infectious Disease, Osmania Medical College | Hyderabad | India | 500012 |
Sponsors and Collaborators
- Augusta University
Investigators
- Principal Investigator: Satish SC Rao, MD,PhD, FRCP(LON), University of Iowa
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Satish Rao,
Professor,
Augusta University
ClinicalTrials.gov Identifier:
NCT00257374
Other Study ID Numbers:
- Gatorade
First Posted:
Nov 22, 2005
Last Update Posted:
Jan 9, 2014
Last Verified:
Jan 1, 2014
Additional relevant MeSH terms: