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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by The Hospital for Sick Children
Sponsor:
Information provided by (Responsible Party):
Stephen Freedman, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT01185054
First received: August 18, 2010
Last updated: December 10, 2013
Last verified: December 2013
  Purpose

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 Intervention Phase
Gastroenteritis
Other: ½ strength apple juice
Other: Pediatric Electrolyte
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Is Electrolyte Maintenance Solution Required in Low-Risk Children With Gastroenteritis?

Resource links provided by NLM:


Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • Proportion of children experiencing a treatment failure [ Time Frame: Within 7 days of enrolment ] [ Designated as safety issue: No ]

    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:
  • Percent Weight Change [ Time Frame: 72-84 hours after enrolment ] [ Designated as safety issue: No ]
  • Proportion of Subjects Receiving Intravenous Rehydration [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Proportion of Subjects Requiring Hospitalization [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Frequency of diarrhea and vomiting episodes [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 624
Study Start Date: November 2010
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   6 Months to 60 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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]
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01185054

Contacts
Contact: Stephen Freedman, MD 416-813-7654 ext 2382 stephen.freedman@sickkids.ca

Locations
Canada, Ontario
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Stephen Freedman, MD    416 813 7654 ext 2382    stephen.freedman@sickkids.ca   
Principal Investigator: Stephen Freedman, MD         
Sub-Investigator: Suzanne Schuh, MD         
Sub-Investigator: Patricia Parkin, MD         
Sub-Investigator: Kathy Boutis, MD         
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Principal Investigator: Stephen Freedman, MD The Hospital for Sick Children, Toronto Canada
  More Information

No publications provided

Responsible Party: Stephen Freedman, Adjunct Scientist, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT01185054     History of Changes
Other Study ID Numbers: 1000017642
Study First Received: August 18, 2010
Last Updated: December 10, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by The Hospital for Sick Children:
Pediatrics
Gastroenteritis
Oral Rehydration
Electrolyte Maintenance Solution

Additional relevant MeSH terms:
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014