Oral Glucose Intervention for Children With Gastroenteritis and Ketosis

Withdrawn

• Conditions: Gastrointestinal Infections; Ketosis
• Interventions: Drug: Oral Glucose Gel; Other: Placebo

• Registration Number: NCT02729870
• Lead Sponsor: University of Florida

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 Description

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.

Study Timeline

• Study First Submitted: 2016-03-29
• Study First Submitted QC: 2016-03-31
• Study First Posted: 2016-04-06
• Status Verified: 2018-01
• Study Start: 2018-01
• Last Update Submitted: 2018-01-25
• Last Update Posted: 2018-01-29
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Participants with gastroenteritis presenting to UF Health Shands Emergency Department

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Exclusion Criteria

• hypoglycemic- Blood glucose less than 50 or hyperglycemic- greater than 200

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Oral Glucose Gel	Oral Glucose Gel	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.
Oral Placebo Gel	Placebo	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.

Primary Outcome Measures

Name	Time	Method
Beta-hydroxybutyrate will be analyzed between the groups	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.

Secondary Outcome Measures

Name	Time	Method
Number of subjects Intravenous (IV)-Hydration between the groups	4 hours	Oral fluid hydration will have failed if subject needs IV fluid.
The amount of oral fluid intake in milliliters will be measured between the groups	Change from 1 hour to 4 hours	Oral fluid consumption will be measured between the groups.
Number of subjects hospitalized between the groups	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.