Skip to main content
Clinical Trials/NCT01185054
NCT01185054CompletedPhase 2

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

The Hospital for Sick Children2 sites in 1 country624 target enrollmentStarted: November 2010Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
624
Locations
2
Primary Endpoint
Proportion of children experiencing a treatment failure

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
6 Months to 60 Months (Child)
Sex
All
Accepts Healthy Volunteers
No

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]

Arms & Interventions

Fluids as Tolerated (FAT) Group

Experimental

The FAT group will receive ½ strength apple juice and will form the experimental group in this study.

Intervention: ½ strength apple juice (Other)

Electrolyte Maintenance Solution (EMS)

Active Comparator

The EMS group will form the control group as solutions such as Pediatric Electrolyte® are routinely recommended for use in children with gastroenteritis.

Intervention: Pediatric Electrolyte (Other)

Outcomes

Primary Outcomes

Proportion of children experiencing a treatment failure

Time Frame: Within 7 days of enrolment

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 Outcomes

  • Proportion of Subjects Requiring Hospitalization(7 days)
  • Frequency of diarrhea and vomiting episodes(7 days)
  • Percent Weight Change(72-84 hours after enrolment)
  • Proportion of Subjects Receiving Intravenous Rehydration(7 days)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Stephen Freedman

Adjunct Scientist

The Hospital for Sick Children

Study Sites (2)

Loading locations...

Similar Trials