NCT02729870

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2018

Shorter than P25 for all trials

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 6, 2016

Completed
1.7 years until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

January 29, 2018

Status Verified

January 1, 2018

Enrollment Period

11 months

First QC Date

March 29, 2016

Last Update Submit

January 25, 2018

Conditions

Gastrointestinal InfectionsKetosis

Keywords

KetonesGastroenteritis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • The amount of oral fluid intake in milliliters will be measured between the groups

    Change from 1 hour to 4 hours

  • Number of subjects Intravenous (IV)-Hydration between the groups

    4 hours

  • Number of subjects hospitalized between the groups

    4 hours

Study Arms (2)

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

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

Interventions

Oral Glucose GelDRUG

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.

Also known as: Dextrose Gel, Glucote
Oral Glucose Gel
PlaceboOTHER

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.

Also known as: carboxymethylcellulose (2%) oral gel
Oral Placebo Gel

Eligibility Criteria

Age1 Year - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Children aged 1-7 years presenting to ED with symptoms of gastroenteritis

You may qualify if:

  • Participants with gastroenteritis presenting to UF Health Shands Emergency Department

You may not qualify if:

  • hypoglycemic- Blood glucose less than 50 or hyperglycemic- greater than 200

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (11)

  • 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.

    PMID: 8604285BACKGROUND

  • 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):e1000350. doi: 10.1371/journal.pmed.1000350.

    PMID: 20967234BACKGROUND

  • 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.

    PMID: 14627948BACKGROUND

  • 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. No abstract available.

    PMID: 25939578BACKGROUND

  • 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.

    PMID: 21262881BACKGROUND

  • 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.

    PMID: 23820403BACKGROUND

  • 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.

    PMID: 22959318BACKGROUND

  • 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.

    PMID: 19148016BACKGROUND

  • 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.

    PMID: 24238317BACKGROUND

  • 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.

    PMID: 24075361BACKGROUND

  • 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. doi: 10.1542/peds.2004-2218.

    PMID: 16263979BACKGROUND

MeSH Terms

Conditions

KetosisGastroenteritis

Interventions

Carboxymethylcellulose SodiumGels

Condition Hierarchy (Ancestors)

AcidosisAcid-Base ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

MethylcelluloseCelluloseGlucansPolysaccharidesCarbohydratesColloidsComplex MixturesDosage FormsPharmaceutical Preparations

Study Officials

  • Fred R Guyer, MD

    University of Florida Assisstant Professor

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2016

First Posted

April 6, 2016

Study Start

January 1, 2018

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

January 29, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will share