Oral Glucose Intervention for Children With Gastroenteritis and Ketosis

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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Recruitment Status : Withdrawn (lack of funding)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

Study Description

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.

Study Design

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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

Drug Information available for: Carboxymethylcellulose sodium Dextrose Croscarmellose sodium

U.S. FDA Resources

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

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 :

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

Eligibility Criteria

Information from the National Library of Medicine

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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

Contacts and Locations

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

More Information

Publications:

Practice parameter: the management of acute gastroenteritis in young children. American Academy of Pediatrics, Provisional Committee on Quality Improvement, Subcommittee on Acute Gastroenteritis. Pediatrics. 1996 Mar;97(3):424-35.

Freedman SB, Steiner MJ, Chan KJ. Oral ondansetron administration in emergency departments to children with gastroenteritis: an economic analysis. PLoS Med. 2010 Oct 12;7(10). pii: e1000350. doi: 10.1371/journal.pmed.1000350.

King CK, Glass R, Bresee JS, Duggan C; Centers for Disease Control and Prevention. Managing acute gastroenteritis among children: oral rehydration, maintenance, and nutritional therapy. MMWR Recomm Rep. 2003 Nov 21;52(RR-16):1-16.

Whyte LA, Al-Araji RA, McLoughlin LM. Guidelines for the management of acute gastroenteritis in children in Europe. Arch Dis Child Educ Pract Ed. 2015 Dec;100(6):308-12. doi: 10.1136/archdischild-2014-307253. Epub 2015 May 4. Review.

Freedman SB, Gouin S, Bhatt M, Black KJ, Johnson D, Guimont C, Joubert G, Porter R, Doan Q, van Wylick R, Schuh S, Atenafu E, Eltorky M, Cho D, Plint A; Pediatric Emergency Research Canada. Prospective assessment of practice pattern variations in the treatment of pediatric gastroenteritis. Pediatrics. 2011 Feb;127(2):e287-95. doi: 10.1542/peds.2010-2214. Epub 2011 Jan 24.

Freedman SB, Thull-Freedman JD, Rumantir M, Atenafu EG, Stephens D. Emergency department revisits in children with gastroenteritis. J Pediatr Gastroenterol Nutr. 2013 Nov;57(5):612-8. doi: 10.1097/MPG.0b013e3182a1dd93.

Levy JA, Bachur RG, Monuteaux MC, Waltzman M. Intravenous dextrose for children with gastroenteritis and dehydration: a double-blind randomized controlled trial. Ann Emerg Med. 2013 Mar;61(3):281-8. doi: 10.1016/j.annemergmed.2012.08.007. Epub 2012 Sep 6.

Reid SR, Losek JD. Rehydration: role for early use of intravenous dextrose. Pediatr Emerg Care. 2009 Jan;25(1):49-52; quiz 53-4. doi: 10.1097/PEC.0b013e318191d97c. Review.

Levy JA, Waltzman M, Monuteaux MC, Bachur RG. Value of point-of-care ketones in assessing dehydration and acidosis in children with gastroenteritis. Acad Emerg Med. 2013 Nov;20(11):1146-50. doi: 10.1111/acem.12256.

Harris DL, Weston PJ, Signal M, Chase JG, Harding JE. Dextrose gel for neonatal hypoglycaemia (the Sugar Babies Study): a randomised, double-blind, placebo-controlled trial. Lancet. 2013 Dec 21;382(9910):2077-83. doi: 10.1016/S0140-6736(13)61645-1. Epub 2013 Sep 25.

Barennes H, Valea I, Nagot N, Van de Perre P, Pussard E. Sublingual sugar administration as an alternative to intravenous dextrose administration to correct hypoglycemia among children in the tropics. Pediatrics. 2005 Nov;116(5):e648-53.

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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

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