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GastroenteritisPhase 2NCT01185054

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

A Phase 2 study testing ½ strength apple juice and Pediatric Electrolyte in people with Gastroenteritis, run by The Hospital for Sick Children at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 6 to 60 months
Conditions the study is for
Gastroenteritis
What is being tested?
½ strength apple juice and Pediatric Electrolyte
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
624 participants
Where
1 siteCanada
Study dates
Nov 2010to May 2015
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 60 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • ≥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
Show all 14Show fewer
  • 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)

Who cannot join

  • 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]

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • The Hospital for Sick Children

    Toronto, Ontario, M5G 1X8

Other trials in Canada

About this study

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.

Read the 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.

Conditions
Gastroenteritis
Being tested
½ strength apple juice, Pediatric Electrolyte
Keywords
Pediatrics, Gastroenteritis, Oral Rehydration, Electrolyte Maintenance Solution
Medical subject headings
Gastroenteritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ½ strength apple juiceOther

    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.

  • Pediatric ElectrolyteOther

    Also called Oral Electrolyte Maintenance Solution

    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.

Study groups in NCT01185054
Study groupRoleWhat they receive
Fluids as Tolerated (FAT) GroupExperimentalThe FAT group will receive ½ strength apple juice and will form the experimental group in this study.
Receives: Other: ½ strength apple juice
Electrolyte Maintenance Solution (EMS)Active comparatorThe EMS group will form the control group as solutions such as Pediatric Electrolyte® are routinely recommended for use in children with gastroenteritis.
Receives: Other: Pediatric Electrolyte

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Within 7 days of enrolment

Secondary outcomes (4)

  1. Percent Weight Change

    Measured: 72-84 hours after enrolment

  2. Proportion of Subjects Receiving Intravenous Rehydration

    Measured: 7 days

  3. Proportion of Subjects Requiring Hospitalization

    Measured: 7 days

  4. Frequency of diarrhea and vomiting episodes

    Measured: 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2010 (estimated)
  2. Study startNov 2010
  3. Primary completionMay 2015
  4. Study completionMay 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
624 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01185054
Sponsor's protocol ID
1000017642
Status last verified
Apr 2018
First submitted
18 Aug 2010
Last updated
17 Apr 2018
Results posted
No
Data monitoring committee
Yes

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.

    PubMed 27131100

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ½ strength apple juice and Pediatric Electrolyte in people with Gastroenteritis, run by The Hospital for Sick Children at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of children experiencing a treatment failure (time frame: Within 7 days of enrolment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01185054, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2018.

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