Sucrose at Triage for Acute Gastroenteritis Episode in Children

NCT05378776 | Completed

• 1 other identifier: 2023-4319
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gastroenteritis Acute; Vomiting

Keywords

children; sucrose; emergency department; triage

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Number of participants who needed an observation

  2 hours

• Number of participants with oral rehydration failure

  6 hours

• Mean number of vomiting

  6 hours

• Number of participants who received ondansetron

  6 hours

• Mean length of stay

  24 hours

Study Arms (2)

Sucrose

EXPERIMENTAL

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.

Dietary Supplement: sucrose

Control

PLACEBO COMPARATOR

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).

Dietary Supplement: Standard rehydration solution

Interventions

sucrose DIETARY_SUPPLEMENT

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.

Sucrose

Standard rehydration solution DIETARY_SUPPLEMENT

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).

Control

Eligibility Criteria

• Age: 6 Months - 83 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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
• Inability to obtain parental informed consent (language barrier, absence, etc.)

Sponsors & Collaborators

• Jocelyn Gravel: lead

Study Sites (1)

Sainte-Justine Hospital

Montreal, Quebec, H3T1C5, Canada

Location

MeSH Terms

Conditions

Vomiting; Emergencies

Interventions

Sucrose

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: It is a blinded study for participants, treating physician and statistician. However, for practical reasons and to minimize cost related to the study preparation, the research nurses/assistants will not be blinded to the treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 6, 2022
• First Posted: May 18, 2022
• Study Start: May 11, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: May 18, 2025

Record last verified: 2025-05

Locations

CA (1)