Clinical trial NCT01185054: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastroenteritis
Keywords: Pediatrics
Gastroenteritis
Oral Rehydration
Electrolyte Maintenance Solution
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2010-08-19
Enrollment: 624
Sex: ALL
Minimum age (years): 6
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 \[Canadian Institute for Health Information (CIHI) follow-up data will not be available\]

Primary outcomes:
measure: Proportion of children experiencing a treatment failure
timeFrame: Within 7 days of enrolment
Secondary outcomes:
measure: Percent Weight Change
timeFrame: 72-84 hours after enrolment
measure: Proportion of Subjects Receiving Intravenous Rehydration
timeFrame: 7 days
measure: Proportion of Subjects Requiring Hospitalization
timeFrame: 7 days
measure: Frequency of diarrhea and vomiting episodes
timeFrame: 7 days
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children, Toronto Canada
name: Stephen Freedman, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.