Oral Glucose Intervention for Children With Gastroenteritis and Ketosis

Ketosis Clinical Trial

Official title:

Oral Glucose Intervention for Children With Gastroenteritis and Ketosis

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02729870
• Other study ID #: IRB201600147
• Status: Withdrawn
• Phase: N/A
• First received: March 29, 2016
• Last updated: January 25, 2018
• Start date: January 2018
• Est. completion date: December 2018

Study information

• Verified date: January 2018
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 7 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastroenteritis
• Gastrointestinal Infections
• Ketosis

Intervention

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:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

References & Publications (11)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Number of subjects Intravenous (IV)-Hydration between the groups	Oral fluid hydration will have failed if subject needs IV fluid.	4 hours
Secondary	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