An observational study in Gastrointestinal Infections and Ketosis, sponsored by University of Florida. Withdrawn. Open to participants aged 1 Year to 7 Years. Per ClinicalTrials.gov, last updated 2018-01-29.
Sponsored by University of Florida · Observational
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.
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.
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Children aged 1-7 years presenting to ED with symptoms of gastroenteritis
Exclusion Criteria:
This group will consist of participants ages 1 - 7. The subject who are less than 3 year of age will receive 7.5 gram oral glucose gel 40% (0.66 oz, 20ml) which will be a one time dose and the subjects who are ages 3-7 will receive 15 gram oral glucose gel (1.3 oz, 40ml) which is a one time dose.
Drug: Oral Glucose Gel
The group will consist of participants ages 1 - 7. The subjects who are less than 3 years of age will receive carboxymethylcellulose (2%) oral gel, 20ml which will be a one time dose and the subjects ages 3- 7 will receive carboxymethylcellulose (2%) oral gel, 40ml which will be a one time dose.
Other: Placebo
This group will receive the following: are less than 3 year of age will receive 7.5 gram oral glucose gel 40% (0.66 oz, 20ml) which will be a one time dose and the subjects who are ages 3-7 will receive 15 gram oral glucose gel (1.3 oz, 40ml) which is a one time dose.
Also known as: Dextrose Gel, Glucote
This group will receive carboxymethylcellulose (2%) oral gel. The subjects who are less than than 3 years of age will receive carboxymethylcellulose (2%) oral gel, 20ml which will be a one time dose and the subjects ages 3-7 will receive carboxymethylcellulose (2%) oral gel, 40ml which will be a one time dose.
Also known as: carboxymethylcellulose (2%) oral gel
Beta-hydroxybutyrate will be analyzed between the groups
Change in beta-hydroxybutyrate will be measured by blood test from -0 hour to 4 hours between the groups.
Time frame: Change from baseline to 4 hours
The amount of oral fluid intake in milliliters will be measured between the groups
Oral fluid consumption will be measured between the groups.
Time frame: Change from 1 hour to 4 hours
Number of subjects Intravenous (IV)-Hydration between the groups
Oral fluid hydration will have failed if subject needs IV fluid.
Time frame: 4 hours
Number of subjects hospitalized between the groups
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.
Time frame: 4 hours
No study locations are listed for this record.
Plan to share: Yes
This study is withdrawn, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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University of Florida