Is Electrolyte Maintenance Solution Required in Low-Risk Children With Gastroenteritis?

Study Overview
=================
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.

Official Title
-----------------
Is Electrolyte Maintenance Solution Required in Low-Risk Children With Gastroenteritis?

Conditions
-----------------
Gastroenteritis

Intervention / Treatment
-----------------
* Other: ½ strength apple juice
* Other: Pediatric Electrolyte


Participation Criteria
=================
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]

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 60 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fluids as Tolerated (FAT) Group<br>The FAT group will receive ½ strength apple juice and will form the experimental group in this study. | Other: ½ strength apple juice<br>* 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.<br>|
| Active Comparator: Electrolyte Maintenance Solution (EMS)<br>The EMS group will form the control group as solutions such as Pediatric Electrolyte® are routinely recommended for use in children with gastroenteritis. | Other: Pediatric Electrolyte<br>* 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.<br>* Other names: Oral Electrolyte Maintenance Solution;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Within 7 days of enrolment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Weight Change |  | 72-84 hours after enrolment | 
| Proportion of Subjects Receiving Intravenous Rehydration |  | 7 days | 
| Proportion of Subjects Requiring Hospitalization |  | 7 days | 
| Frequency of diarrhea and vomiting episodes |  | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pediatrics, Gastroenteritis, Oral Rehydration, Electrolyte Maintenance Solution