NCT05378776: STAGE

Sucrose at Triage for Acute Gastroenteritis Episode in Children

Completed NA Last updated 18 May 2025

What this trial tests

NA trial testing sucrose in Gastroenteritis Acute in 240 participants. Completed in 31 December 2024.

Timeline

11 May 2022

Primary endpoint
31 December 2024

31 December 2024

Quick facts

Lead sponsor	Jocelyn Gravel
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	240
Start date	11 May 2022
Primary completion	31 December 2024
Estimated completion	31 December 2024
Sites	1 location across Canada

Drugs / interventions tested

• sucrose — full drug profile →
• Standard rehydration solution

Conditions studied

• Gastroenteritis Acute — all drugs for Gastroenteritis Acute →
• Vomiting — all drugs for Vomiting →

Sponsor

Jocelyn Gravel

Who can join

Adults 6 Months to 83 Months, any sex, with Gastroenteritis Acute or Vomiting. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background: Acute viral gastroenteritis is a very common pediatric medical condition that results in a large number of emergency department (ED) visits. Fasting-induced ketosis has been suggested to contribute to nausea and vomiting in children with VGE. To date, there is no data on the impact of oral sucrose intake during oral rehydration.

Objective: The aim of this study is to assess the impact of providing a sucrose solution at triage to young children with suspected acute viral gastroenteritis on the amount of rehydration solution intake in the first 2 hours. We will also assess the proportion of discharge after initial medical evaluation, the proportion of oral rehydration failure, the number of vomiting episodes per patient, ondansetron administration, the time between the intervention and ED discharge, the time between the first medical contact and ED discharge and return visits within 48 hours.

Methods:

This study will be a double-blind randomized controlled trial. Recruitment will take place in a tertiary pediatric ED. Participants will be all children who present to the ED with suspected acute acute viral gastroenteritis with at least three vomiting in the previous 24 hours. The intervention will consist in giving 1.5 ml/kg of a sucrose solution composed of diluted juice with added table sugar (3.5g of sucrose/10 ml) compared with 1.5 ml/kg of diluted juice (0.5g of sucrose/10 mL, standard of care in our ED). Following that, all participants will be rehydrated with 15 mL of diluted juice every 15 minutes or more if tolerated. The primary outcome will be the amount of rehydration solution (ml) absorbed in the first two hours following intervention. Secondary outcomes will include disposition after initial medical evaluation, oral rehydration failure, the number of vomiting, ondansetron administration, the time between the intervention and ED discharge, the time between the first medical contact and ED discharge and return visits within 48 hours. The primary analysis will be the difference in the amount of tolerated oral rehydration between the two groups. Based on a preliminary study of children suffering from VGE, it was estimated that the recruitment of 238 participants would provide a power of 80% to identify a difference of 15 ml between the two groups.

Expected results:

We hope that this study will demonstrate that an oral sucrose solution given at triage to children presenting with symptoms compatible with acute acute viral gastroenteritis promotes oral hydration and consequently increases the total amount of rehydration solution tolerated by children.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.