Gastroenteritis AcuteSTAGENCT05378776
Sucrose at Triage for Acute Gastroenteritis Episode in Children
A study testing sucrose and Standard rehydration solution in people with Gastroenteritis Acute and Vomiting, run by Jocelyn Gravel at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 6 to 83 months
- Conditions the study is for
- Gastroenteritis Acute, Vomiting
- What is being tested?
- sucrose and Standard rehydration solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteCanada
- Study dates
- 11 May 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 83 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Triage Administration of Sucrose for Gastroenteritis in Children; a Randomized Controlled Trial
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.
Read more
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
- Being tested
- sucrose, Standard rehydration solution
- Keywords
- children, sucrose, emergency department, triage
- Medical subject headings
- Vomiting, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sucroseDietary 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.
Standard rehydration solutionDietary 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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Dietary Supplement: Standard rehydration solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 hours after intervention
Secondary outcomes (7)
Number of participants who needed an observation
Patient who are not immediately discharged by the treating physician after the first evaluation
Measured: 2 hours
Number of participants with oral rehydration failure
Patient who need an intravenous rehydration during ED stay
Measured: 6 hours
Mean number of vomiting
Number of vomiting episode per patient during ED stay
Measured: 6 hours
Number of participants who received ondansetron
Number of patients who received ondansetron during ED stay
Measured: 6 hours
Mean length of stay
The time between the intervention and ED discharge
Measured: 24 hours
Mean length of stay after physician evaluation
The time between the first evaluation by a physician and ED discharge
Measured: 24 hours
Number of participants who had a return visit
return visit to the ED
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start11 May 2022
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroenteritis AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jocelyn Gravel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jocelyn Gravel, St. Justine's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05378776
- Sponsor's protocol ID
- 2023-4319
- Acronym
- STAGE
- Status last verified
- May 2025
- First submitted
- 6 May 2022
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Triage Administration of Sucrose for Gastroenteritis in Children; a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05378776
- Acronym / sponsor ID
- STAGE / 2023-4319
- Conditions
- Gastroenteritis Acute, Vomiting
- Keywords
- children, sucrose, emergency department, triage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Jocelyn GravelUniversity, hospital or other
- Study start
- 11 May 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 18 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sucrose | Experimental | Dietary Supplement: sucroseThe 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. |
| Control | Placebo comparator | Dietary Supplement: Standard rehydration solutionThis 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). |
Who may qualify
- Ages
- 6 to 83 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sucroseThe 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. | Dietary supplement | Sucrose |
| Standard rehydration solutionThis 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 | Control |
Primary outcome
Mean amount of tolerated oral rehydration in mL
Time frame: 2 hours after intervention
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.
7 secondary outcomes
Number of participants who needed an observation
Time frame: 2 hours
Number of participants with oral rehydration failure
Time frame: 6 hours
Mean number of vomiting
Time frame: 6 hours
Number of participants who received ondansetron
Time frame: 6 hours
Mean length of stay
Time frame: 24 hours
Mean length of stay after physician evaluation
Time frame: 24 hours
Number of participants who had a return visit
Time frame: 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Gastroenteritis Acute
RecruitingObservational study
Prospective Comparison of Pro-Adrenomedullin, C-Reactive Protein, and Neutrophil-to-Lymphocyte Ratio for Diagnosing Acute Appendicitis
Acute Appendicitis
Not yet recruitingObservational study
Cardiovascular Risk in Patients With IBD
Ulcerative Colitis (UC), Crohn's Diseases
Recruiting
Feasibility and Safety of a Pediatric ERAS Protocol for Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Acute Appendicitis
Not yet recruiting
Automatic Versus As-Needed Follow-up After Hospitalization for Children With Medical Complexity
Children With Medical Complexity, Respiratory Tract Infections (RTI)
Not yet recruitingPhase 2
Patient Choice Between Antibiotics and Appendectomy in Uncomplicated Appendicitis (FRENCH 47 - ALACARTE)
Acute Appendicitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sucrose and Standard rehydration solution in people with Gastroenteritis Acute and Vomiting, run by Jocelyn Gravel at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean amount of tolerated oral rehydration in mL (time frame: 2 hours after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025.