Is Electrolyte Maintenance Solution Required in Low-Risk Children With Gastroenteritis?
Primary Purpose
Gastroenteritis
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
½ strength apple juice
Pediatric Electrolyte
Sponsored by
About this trial
This is an interventional treatment trial for Gastroenteritis focused on measuring Pediatrics, Gastroenteritis, Oral Rehydration, Electrolyte Maintenance Solution
Eligibility Criteria
Inclusion Criteria:
- ≥3 episodes of vomiting or diarrhea in preceding 24 hours
- Duration of illness less than 96 hours
- Age 6 - 60 months
- Clinical suspicion of acute intestinal infectious process
- Weight ≥ 8 kg
- Clinical dehydration score < 5
- Capillary refill < 2 seconds
- Absence of bulging fontanelle
- Absence of bilious vomiting
- Absence of blood in diarrhea/emesis
- Absence of abdominal pain (if present reported as periumbilical in location)
- Absence of abdominal distention
- Absence of acute disease currently requiring treatment
- Absence of co-existing diseases (prematurity, cardiac, renal, neurological, metabolic, endocrine, immunodeficiency, trauma or history of ingestion)
Exclusion Criteria:
- Known gastrointestinal diseases (ie. inflammatory bowel disease, celiac) or any other underlying disease process that might place the child at an increased risk of treatment failure.
- Age < 6 months
- Weight < 8 kg
- If premature, corrected gestational age < 30 weeks
- Presence of hematochezia
- Responsible physician judges the child requires immediate intravenous rehydration
- English language is so limited that consent and/or follow-up is not possible.
- Non-Ontario resident [Canadian Institute for Health Information (CIHI) follow-up data will not be available]
Sites / Locations
- The Hospital for Sick Children
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Fluids as Tolerated (FAT) Group
Electrolyte Maintenance Solution (EMS)
Arm Description
The FAT group will receive ½ strength apple juice and will form the experimental group in this study.
The EMS group will form the control group as solutions such as Pediatric Electrolyte® are routinely recommended for use in children with gastroenteritis.
Outcomes
Primary Outcome Measures
Proportion of children experiencing a treatment failure
This outcome will be deemed to have occurred if any of the following occur:
Requires an unscheduled visit after the initial encounter
Requires physician evaluation during a follow-up assessment.
Hospitalization or Intravenous Rehydration
Extended Symptomatology
Failure to consume sufficient study fluid during the initial ED visit
Secondary Outcome Measures
Percent Weight Change
Proportion of Subjects Receiving Intravenous Rehydration
Proportion of Subjects Requiring Hospitalization
Frequency of diarrhea and vomiting episodes
Full Information
NCT ID
NCT01185054
First Posted
August 18, 2010
Last Updated
April 16, 2018
Sponsor
The Hospital for Sick Children
1. Study Identification
Unique Protocol Identification Number
NCT01185054
Brief Title
Is Electrolyte Maintenance Solution Required in Low-Risk Children With Gastroenteritis?
Official Title
Is Electrolyte Maintenance Solution Required in Low-Risk Children With Gastroenteritis?
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The objective of this study is to clarify the current standard of care by determining if Electrolyte Maintenance Solution (EMS) is truly the optimal fluid to be used in low-risk children who present to an Emergency Department (ED) with < 72 hours of vomiting or diarrhea.
Detailed Description
Gastroenteritis remains a major cause of morbidity amongst Canadian children. The primary treatment focus revolves around the use of Oral Rehydration Therapy (ORT) to treat dehydration and replace intravascular volume. Since diarrheal disease in Canadian children usually results in mild dehydration and minimal sodium losses, the use of low sodium Electrolyte Maintenance Solutions (EMS) has become the standard of care. However, given that North American children infrequently develop severe dehydration, it is unclear if the routine use of EMS is justified. When pediatricians directly dispense EMS, 16 children need to be treated to prevent 1 unscheduled office visit, however the upper bound of the 95% confidence interval is an astounding 508 patients. In addition, EMS is considered by some to be prohibitively expensive, with 15% of pediatricians believing it to be too expensive for their patients to purchase. An additional 40% report that taste is a major barrier to consumption. As a result, oral fluid replenishment is often underutilized and IV rehydration employed instead. Our goal is to provide evidence to guide the selection of the optimal ORT fluids in low-risk children, thus increasing its use, enhancing its success, and reducing the reliance on intravenous rehydration. We hypothesize that the strict adherence to EMS use in low-risk children may actually be counterproductive by resulting in reduced fluid intake and potentially increasing the use of intravenous rehydration.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroenteritis
Keywords
Pediatrics, Gastroenteritis, Oral Rehydration, Electrolyte Maintenance Solution
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
624 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fluids as Tolerated (FAT) Group
Arm Type
Experimental
Arm Description
The FAT group will receive ½ strength apple juice and will form the experimental group in this study.
Arm Title
Electrolyte Maintenance Solution (EMS)
Arm Type
Active Comparator
Arm Description
The EMS group will form the control group as solutions such as Pediatric Electrolyte® are routinely recommended for use in children with gastroenteritis.
Intervention Type
Other
Intervention Name(s)
½ strength apple juice
Intervention Description
For each episode of diarrhea 10 ml/kg of fluid will be given and for each episode of vomiting 2 ml/kg will be given. If the child does not like the solution another fluid can be used.
Intervention Type
Other
Intervention Name(s)
Pediatric Electrolyte
Other Intervention Name(s)
Oral Electrolyte Maintenance Solution
Intervention Description
For each episode of diarrhea 10 ml/kg of fluid will be given and for each episode of vomiting 2 ml/kg will be given. If the child does not like the solution another electrolyte maintenance fluid can be used. Fluids containing non-physiological concentrations of glucose and electrolytes (carbonated drinks, sweetened fruit juices, water) will be discouraged.
Primary Outcome Measure Information:
Title
Proportion of children experiencing a treatment failure
Description
This outcome will be deemed to have occurred if any of the following occur:
Requires an unscheduled visit after the initial encounter
Requires physician evaluation during a follow-up assessment.
Hospitalization or Intravenous Rehydration
Extended Symptomatology
Failure to consume sufficient study fluid during the initial ED visit
Time Frame
Within 7 days of enrolment
Secondary Outcome Measure Information:
Title
Percent Weight Change
Time Frame
72-84 hours after enrolment
Title
Proportion of Subjects Receiving Intravenous Rehydration
Time Frame
7 days
Title
Proportion of Subjects Requiring Hospitalization
Time Frame
7 days
Title
Frequency of diarrhea and vomiting episodes
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
60 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
≥3 episodes of vomiting or diarrhea in preceding 24 hours
Duration of illness less than 96 hours
Age 6 - 60 months
Clinical suspicion of acute intestinal infectious process
Weight ≥ 8 kg
Clinical dehydration score < 5
Capillary refill < 2 seconds
Absence of bulging fontanelle
Absence of bilious vomiting
Absence of blood in diarrhea/emesis
Absence of abdominal pain (if present reported as periumbilical in location)
Absence of abdominal distention
Absence of acute disease currently requiring treatment
Absence of co-existing diseases (prematurity, cardiac, renal, neurological, metabolic, endocrine, immunodeficiency, trauma or history of ingestion)
Exclusion Criteria:
Known gastrointestinal diseases (ie. inflammatory bowel disease, celiac) or any other underlying disease process that might place the child at an increased risk of treatment failure.
Age < 6 months
Weight < 8 kg
If premature, corrected gestational age < 30 weeks
Presence of hematochezia
Responsible physician judges the child requires immediate intravenous rehydration
English language is so limited that consent and/or follow-up is not possible.
Non-Ontario resident [Canadian Institute for Health Information (CIHI) follow-up data will not be available]
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Freedman, MD
Organizational Affiliation
The Hospital for Sick Children, Toronto Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
27131100
Citation
Freedman SB, Willan AR, Boutis K, Schuh S. Effect of Dilute Apple Juice and Preferred Fluids vs Electrolyte Maintenance Solution on Treatment Failure Among Children With Mild Gastroenteritis: A Randomized Clinical Trial. JAMA. 2016 May 10;315(18):1966-74. doi: 10.1001/jama.2016.5352.
Results Reference
derived
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Is Electrolyte Maintenance Solution Required in Low-Risk Children With Gastroenteritis?
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