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

NCT01185054 | Completed Phase 2 DMC

• 1 other identifier: 1000017642
• Study Type: interventional
• Target: 624
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastroenteritis

Keywords

Pediatrics; Gastroenteritis; Oral Rehydration; Electrolyte Maintenance Solution

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (2)

Fluids as Tolerated (FAT) Group

EXPERIMENTAL

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

Other: ½ strength apple juice

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.

Other: Pediatric Electrolyte

Interventions

½ strength apple juice OTHER

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.

Fluids as Tolerated (FAT) Group

Pediatric Electrolyte OTHER

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.

Also known as: Oral Electrolyte Maintenance Solution

Electrolyte Maintenance Solution (EMS)

Eligibility Criteria

• Age: 6 Months - 60 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• ≥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)

You may not qualify if:

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

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Related Publications (1)

• 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.

  PMID: 27131100 DERIVED

MeSH Terms

Conditions

Gastroenteritis

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Stephen Freedman, MD

  The Hospital for Sick Children, Toronto Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Scientist

Study Record Dates

• First Submitted: August 18, 2010
• First Posted: August 19, 2010
• Study Start: November 1, 2010
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: April 17, 2018

Record last verified: 2018-04

Locations

CA (1)