Status:
COMPLETED
Is Electrolyte Maintenance Solution Required in Low-Risk Children With Gastroenteritis?
Lead Sponsor:
The Hospital for Sick Children
Conditions:
Gastroenteritis
Eligibility:
All Genders
6-60 years
Phase:
PHASE2
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 t...
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 int...
Eligibility Criteria
Inclusion
- ≥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
- 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 \[Canadian Institute for Health Information (CIHI) follow-up data will not be available\]
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
624 Patients enrolled
Trial Details
Trial ID
NCT01185054
Start Date
November 1 2010
End Date
May 1 2015
Last Update
April 17 2018
Active Locations (1)
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1
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8