Oral Glucose Intervention for Children With Gastroenteritis and Ketosis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Oral Glucose Intervention for Children With Gastroenteritis and Ketosis

Conditions
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Gastrointestinal Infections, Ketosis

Intervention / Treatment
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* Drug: Oral Glucose Gel
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants with gastroenteritis presenting to UF Health Shands Emergency Department Exclusion Criteria: hypoglycemic- Blood glucose less than 50 or hyperglycemic- greater than 200

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Oral Glucose Gel<br>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<br>* 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.<br>* Other names: Glucote;|
| Oral Placebo Gel<br>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<br>* 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.<br>* Other names: carboxymethylcellulose (2%) oral gel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Change from baseline to 4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The amount of oral fluid intake in milliliters will be measured between the groups | Oral fluid consumption will be measured between the groups. | 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. | 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. | 4 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ketones, Gastroenteritis