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

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.

Study Overview

• Status: Completed
• Conditions: Gastroenteritis
• Intervention / Treatment: Other: ½ strength apple juice; Other: Pediatric Electrolyte

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 Type: Interventional
• Enrollment (Actual): 624
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X8
      • The Hospital for Sick Children

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 5 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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]

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Fluids as Tolerated (FAT) Group; The FAT group will receive ½ strength apple juice and will form the experimental group in this study.	Other: ½ strength apple juice; 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.
ACTIVE_COMPARATOR: Electrolyte Maintenance Solution (EMS); 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; 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.; 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	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

Collaborators and Investigators

• Sponsor: The Hospital for Sick Children
• Investigators: Principal Investigator: Stephen Freedman, MD, The Hospital for Sick Children, Toronto Canada

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (ACTUAL): May 1, 2015
• Study Completion (ACTUAL): May 1, 2015

Study Registration Dates

• First Submitted: August 18, 2010
• First Submitted That Met QC Criteria: August 18, 2010
• First Posted (ESTIMATE): August 19, 2010

Study Record Updates

• Last Update Posted (ACTUAL): April 17, 2018
• Last Update Submitted That Met QC Criteria: April 16, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Gastroenteritis; Pediatrics; Oral Rehydration; Electrolyte Maintenance Solution
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis
• Other Study ID Numbers: 1000017642