Oral Glucose Intervention for Children With Gastroenteritis and Ketosis

University of Florida

Status: Withdrawn

Conditions: Ketosis; Gastrointestinal Infections

Treatments: Other: Placebo; Drug: Oral Glucose Gel

Study type: Observational

Funder types: Other

Identifiers

NCT02729870

IRB201600147

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 1 to 7 years old

Volunteers: No Healthy Volunteers

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

Trial design

0 participants in 2 patient groups

Oral Glucose Gel

Description:

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.

Treatment:

Drug: Oral Glucose Gel

Oral Placebo Gel

Description:

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.

Treatment:

Other: Placebo