Status:
COMPLETED
Emergency Department Rapid Intravenous Rehydration (RIVR) for Pediatric Gastroenteritis
Lead Sponsor:
The Hospital for Sick Children
Collaborating Sponsors:
The Physicians' Services Incorporated Foundation
Conditions:
Gastroenteritis
Dehydration
Eligibility:
All Genders
90-18 years
Phase:
PHASE4
Brief Summary
This study will look at children with dehydration secondary to gastroenteritis requiring IV rehydration and determine whether the proportion rehydrated after two hours is greater in the children who r...
Detailed Description
Despite a movement toward increased use of enteral rehydration, many children still receive prolonged IV rehydration in the emergency department (ED). These children commonly receive a single IV bolus...
Eligibility Criteria
Inclusion
- Acute gastroenteritis as determined by the supervising physician.
- Age greater than 90 days
- Dehydrated and unable to consume sufficient oral fluids to overcome their dehydration state
Exclusion
- Weight less than 5 kg or greater than 33 kg
- Underlying disease which may limit the amount of IV fluids given,including but not limited to: hypoalbuminemic states, renal insufficiency, heart disease requiring pharmacotherapy or lesions that may predispose to congestive heart failure, hypertension, chronic lung disease (excluding asthma), diabetes mellitus, severe anemia, and chronic inflammatory disease
- Clinical suspicion by the attending physician of myocarditis or previously undiagnosed cardiac or renal disease.
- History of abdominal surgery or concern regarding an acute surgical abdomen
- Significant head, chest or abdominal trauma within the preceding 7 days
- Bilious or bloody vomitus
- Evidence of hemodynamic compromise (BP \< 80 + 2 \* age (yrs)) requiring \> 20 mL/kg 0.9% normal saline to be administered in the 1st hour
- Bedside glucose \< 2.8 mmol/L (see Section 8.3)
- Unable to provide a telephone number or unavailable for follow-up
- Previously enrolled in this trial
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
226 Patients enrolled
Trial Details
Trial ID
NCT00392145
Start Date
November 1 2006
End Date
May 1 2010
Last Update
April 17 2018
Active Locations (1)
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1
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8