An interventional study of sucrose and Standard rehydration solution in Gastroenteritis Acute and Vomiting, sponsored by Jocelyn Gravel. Completed at 1 site in Canada. Open to participants aged 6 Months to 83 Months. Per ClinicalTrials.gov, last updated 2025-05-18.
Sponsored by Jocelyn Gravel · Not applicable, Interventional, and Treatment
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.
793 studies on the registry are indexed under Vomiting; 99 are open to participants now.
This study's enrollment of 240 is above the median of 103 across 673 interventional studies indexed under Vomiting.
Browse Vomiting studies →This is the only study on the registry with Jocelyn Gravel as lead sponsor.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
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).
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.
Time frame: 2 hours after intervention
Number of participants who needed an observation
Patient who are not immediately discharged by the treating physician after the first evaluation
Time frame: 2 hours
Number of participants with oral rehydration failure
Patient who need an intravenous rehydration during ED stay
Time frame: 6 hours
Mean number of vomiting
Number of vomiting episode per patient during ED stay
Time frame: 6 hours
Number of participants who received ondansetron
Number of patients who received ondansetron during ED stay
Time frame: 6 hours
Mean length of stay
The time between the intervention and ED discharge
Time frame: 24 hours
Mean length of stay after physician evaluation
The time between the first evaluation by a physician and ED discharge
Time frame: 24 hours
Number of participants who had a return visit
return visit to the ED
Time frame: 48 hours
Plan to share: Undecided
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This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Sucrose