Sucrose at Triage for Acute Gastroenteritis Episode in Children (STAGE)

Jocelyn Gravel

Status: Completed

Conditions: Vomiting; Gastroenteritis Acute

Treatments: Dietary Supplement: Standard rehydration solution; Dietary Supplement: sucrose

Study type: Interventional

Funder types: Other

Identifiers

NCT05378776

2023-4319

Details and patient eligibility

About

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.

Enrollment: 240 patients

Sex: All

Ages: 6 to 83 months old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

240 participants in 2 patient groups, including a placebo group

Sucrose

Experimental group

Description:

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 diluted juice (see standard arm description) to obtain a solution with the same appearance as the standard arm.

Treatment:

Dietary Supplement: sucrose

Control

Placebo Comparator group

Description:

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).

Treatment:

Dietary Supplement: Standard rehydration solution