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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01185054
Recruitment Status : Completed
First Posted : August 19, 2010
Last Update Posted : April 17, 2018
Information provided by (Responsible Party):
Stephen Freedman, The Hospital for Sick Children

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.

Condition or disease Intervention/treatment Phase
Gastroenteritis Other: ½ strength apple juice Other: Pediatric Electrolyte Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 624 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Is Electrolyte Maintenance Solution Required in Low-Risk Children With Gastroenteritis?
Study Start Date : November 2010
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gastroenteritis

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 Name: Oral Electrolyte Maintenance Solution

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Percent Weight Change [ Time Frame: 72-84 hours after enrolment ]
  2. Proportion of Subjects Receiving Intravenous Rehydration [ Time Frame: 7 days ]
  3. Proportion of Subjects Requiring Hospitalization [ Time Frame: 7 days ]
  4. Frequency of diarrhea and vomiting episodes [ Time Frame: 7 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 60 Months   (Child)
Sexes Eligible for Study:   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]

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01185054

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Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
The Hospital for Sick Children
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Principal Investigator: Stephen Freedman, MD The Hospital for Sick Children, Toronto Canada
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Stephen Freedman, Adjunct Scientist, The Hospital for Sick Children Identifier: NCT01185054    
Other Study ID Numbers: 1000017642
First Posted: August 19, 2010    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018
Keywords provided by Stephen Freedman, The Hospital for Sick Children:
Oral Rehydration
Electrolyte Maintenance Solution
Additional relevant MeSH terms:
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Gastrointestinal Diseases
Digestive System Diseases