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Oral Glucose Intervention for Children With Gastroenteritis and Ketosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02729870
Recruitment Status : Withdrawn (lack of funding)
First Posted : April 6, 2016
Last Update Posted : January 29, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Gastrointestinal Infections Ketosis Drug: Oral Glucose Gel Other: Placebo

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.

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Oral Glucose Intervention for Children With Gastroenteritis and Ketosis
Estimated Study Start Date : January 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gastroenteritis

Group/Cohort Intervention/treatment
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.
Drug: Oral Glucose Gel
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.
Other Names:
  • Dextrose Gel
  • Glucote

Oral Placebo 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 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.
Other Name: carboxymethylcellulose (2%) oral gel




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Number of subjects Intravenous (IV)-Hydration between the groups [ Time Frame: 4 hours ]
    Oral fluid hydration will have failed if subject needs IV fluid.

  3. 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.



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Ages Eligible for Study:   1 Year to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Children aged 1-7 years presenting to ED with symptoms of gastroenteritis
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02729870


Sponsors and Collaborators
University of Florida
Investigators
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Principal Investigator: Fred R Guyer, MD University of Florida Assisstant Professor
Publications:

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02729870    
Other Study ID Numbers: IRB201600147
First Posted: April 6, 2016    Key Record Dates
Last Update Posted: January 29, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by University of Florida:
Ketones
Gastroenteritis
Additional relevant MeSH terms:
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Gastroenteritis
Ketosis
Gastrointestinal Diseases
Digestive System Diseases
Acidosis
Acid-Base Imbalance
Metabolic Diseases
Carboxymethylcellulose Sodium
Laxatives
Gastrointestinal Agents