Sucrose at Triage for Acute Gastroenteritis Episode in Children

Vomiting Clinical Trial

— STAGE  

Official title:

Triage Administration of Sucrose for Gastroenteritis in Children; a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05378776
• Other study ID #: 2023-4319
• Status: Recruiting
• Phase: N/A
• Start date: May 11, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: St. Justine's Hospital
• Contact: Jocelyn Gravel, MD
• Phone: 15143454931
• Email: graveljocelyn[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 238
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 83 Months

Eligibility

Inclusion Criteria:

• Children aged 6 months to 6 years. We will restrict to this age group to have a more homogenous group.
• At least 3 non-bilious, non-bloody, vomiting in the last 24 hours
• No other diagnostic more likely than acute viral gastroenteritis suspected at triage

Exclusion Criteria:

• Severe dehydration (based on poor capillary refill or hypotension)
• Hypoglycemia identified by the triage nurse (< 2,8 mmol)
• Bilious or bloody vomiting
• Chronic disease other than asthma
• Previous inclusion in the study
• Inability to obtain parental informed consent (language barrier, absence, etc.)

Related Conditions & MeSH terms

• Gastroenteritis
• Vomiting

Intervention

Dietary Supplement:
• sucrose
The experimental arm will receive 1.5 ml/kg of the sucrose solution at triage (once). The composition of the homemade sucrose solution used in our emergency department is 3.5 g of table sugar (sucrose) mixed with 10 ml of water. For this double-blind study, we replaced water with diluted juice (see standard arm description) to obtain a solution with the same appearance as the standard arm. With the idea of correcting ketosis, we chose to provide the same amount of sugar as we do in hypoglycemia (0.4-0.5 g/kg of dextrose) to participants in the intervention group, which represents 1.5 ml/kg of the sucrose solution containing 0.4 g of sucrose/mL for a total of 0.6 g/kg of sucrose.
• Standard rehydration solution
This group will receive 1.5 mL/kg of diluted juice composed of juice (apple or orange) and water in equal proportion once at triage. This solution contains 0.05 g/ml of sucrose for a total of 0.075 g/kg of sucrose (eight times less than the intervention arm).

Locations

Country	Name	City	State
Canada	Sainte-Justine Hospital	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Jocelyn Gravel

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean amount of tolerated oral rehydration in mL	The total amount of rehydration solution tolerated during the two hours following intervention. This will be the amount of solution absorbed by the child without vomiting. In case of vomiting, the amount of solution absorbed will be the amount of solution tolerated after vomiting. In the few situations when the children will be discharged from the ED before two hours, we will collect the amount of solution tolerated before discharge.	2 hours after intervention
Secondary	Number of participants who needed an observation	Patient who are not immediately discharged by the treating physician after the first evaluation	2 hours
Secondary	Number of participants with oral rehydration failure	Patient who need an intravenous rehydration during ED stay	6 hours
Secondary	Mean number of vomiting	Number of vomiting episode per patient during ED stay	6 hours
Secondary	Number of participants who received ondansetron	Number of patients who received ondansetron during ED stay	6 hours
Secondary	Mean length of stay	The time between the intervention and ED discharge	24 hours
Secondary	Mean length of stay after physician evaluation	The time between the first evaluation by a physician and ED discharge	24 hours
Secondary	Number of participants who had a return visit	return visit to the ED	48 hours