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

The Hospital for Sick Children

Status and phase: Completed; Phase 2

Conditions: Gastroenteritis

Treatments: Other: Pediatric Electrolyte; Other: ½ strength apple juice

Study type: Interventional

Funder types: Other

Identifiers

NCT01185054

1000017642

Details and patient eligibility

About

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.

Full 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.

Enrollment: 624 patients

Sex: All

Ages: 6 to 60 months old

Volunteers: No Healthy Volunteers

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]

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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624 participants in 2 patient groups

Fluids as Tolerated (FAT) Group

Experimental group

Description:

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

Treatment:

Other: ½ strength apple juice

Electrolyte Maintenance Solution (EMS)

Active Comparator group

Description:

The EMS group will form the control group as solutions such as Pediatric Electrolyte® are routinely recommended for use in children with gastroenteritis.

Treatment:

Other: Pediatric Electrolyte