Clinical Trial: Oral Glucose Intervention for Children With Gastroenteritis and Ketosis

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Observational

Official Title: Oral Glucose Intervention for Children With Gastroenteritis and Ketosis

Brief Summary: Fasting ketoacidosis adds morbidity to children affected by gastrointestinal infections. The investigators investigate oral glucose gel for its effectiveness in rapidly reducing ketoacidosis and for improvements in oral hydration therapy success.

Detailed Summary: More than 1.7 million children with acute gastroenteritis present for emergency department (ED) care annually in the United States. Gastroenteritis treatment regimens have been outlined in guidelines endorsed by the American Academy of Pediatrics, European Society of Pediatric Gastroenterology Hepatology and Nutrition (ESPGHAN), and Center for Disease Control (CDC). A fundamental principle included in these guidelines is the administration of oral rehydration therapy (ORT) to the vast majority of children with gastroenteritis; however, surveys have shown that a gap exists between guidelines and practice. Fasting ketoacidosis is an increasingly recognized metabolic derangement for children presenting with symptoms suggestive of gastroenteritis and mild to moderate dehydration. Ketoacidosis frequently occurs and likely adds comorbid symptoms of lethargy, vomiting, and malaise. These symptoms likely impair successful oral rehydration interventions. These symptoms may also lead to overestimations of the severity of dehydration. Rapid recognition of ketoacidosis is now possible with point of care testing beta-hydroxybutyrate. This investigation will determine if an oral glucose gel intervention will improve the Point Of Care (POC) beta-hydroxybutyrate from baseline. Secondary outcomes measured will include net fluid volume intake estimates, need for IV hydration, and need for hospitalization.
Sponsor: University of Florida

Current Primary Outcome: Beta-hydroxybutyrate will be analyzed between the groups [ Time Frame: Change from baseline to 4 hours ]

Change in beta-hydroxybutyrate will be measured by blood test from -0 hour to 4 hours between the groups.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • The amount of oral fluid intake in milliliters will be measured between the groups [ Time Frame: Change from 1 hour to 4 hours ]
    Oral fluid consumption will be measured between the groups.
  • Number of subjects Intravenous (IV)-Hydration between the groups [ Time Frame: 4 hours ]
    Oral fluid hydration will have failed if subject needs IV fluid.
  • Number of subjects hospitalized between the groups [ Time Frame: 4 hours ]
    The number of subjects with successful hydration can go home, however, the number of subjects who have to be hospitalized between the groups will be noted.


Original Secondary Outcome: Same as current

Information By: University of Florida

Dates:
Date Received: March 29, 2016
Date Started: June 2017
Date Completion: August 2017
Last Updated: February 22, 2017
Last Verified: February 2017