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

Gastroenteritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01185054
• Other study ID #: 1000017642
• Status: Completed
• Phase: Phase 2
• First received: August 18, 2010
• Last updated: April 16, 2018
• Start date: November 2010
• Est. completion date: May 2015

Study information

• Verified date: April 2018
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 624
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 60 Months

Eligibility

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]

Related Conditions & MeSH terms

• Gastroenteritis

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percent Weight Change		72-84 hours after enrolment
Secondary	Proportion of Subjects Receiving Intravenous Rehydration		7 days
Secondary	Proportion of Subjects Requiring Hospitalization		7 days
Secondary	Frequency of diarrhea and vomiting episodes		7 days