Emergency Department Rapid Intravenous Rehydration (RIVR) for Pediatric Gastroenteritis

Study Overview
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Brief Summary
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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 receive rapid intravenous rehydration (RIVR) or in the children who receive standard IV rehydration.

Detailed Description
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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 of normal saline followed by the administration of a hypotonic solution at a maintenance rate. The mean time spent in the ED by children receiving IV rehydration is significantly longer than the mean time required to treat all other conditions. ED overcrowding has been associated with poor outcomes, prolonged pain and suffering, and dissatisfaction. One of the solutions proposed in the American Academy of Pediatrics Policy Statement on ED overcrowding is that hospitals should strive to improve the efficiency of the care provided. One small step in this direction may be to improve our management of gastroenteritis and dehydration.

Official Title
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Emergency Department Rapid Intravenous Rehydration (RIVR) for Pediatric Gastroenteritis: A Randomized Controlled Trial

Conditions
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Gastroenteritis, Dehydration

Intervention / Treatment
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* Drug: Standard IV rehydration
* Drug: Rapid intravenous rehydration (RIVR)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 90 Days
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Drug: Standard IV rehydration<br>* A 20 mL/kg 0.9% normal saline bolus (maximum 999 mL) will be administered over 1 hour. This will be followed by D5-0.9% normal saline at a maintenance rate (maximum 55 mL/hr).<br>|
| Experimental: 2<br> | Drug: Rapid intravenous rehydration (RIVR)<br>* A 60 mL/kg 0.9% normal saline bolus (maximum 999 mL) over 1 hour will be administered. This will be followed by D5-0.9% normal saline at a maintenance rate (maximum 55 mL/hr).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rehydration criteria defined by: dehydration score ≤ 1, normal capillary refill time, normal skin turgor, normal respiratory rate |  | 2 hours following the initiation of IV rehydration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospitalization |  | 72 hours | 
| Ability to tolerate oral rehydration |  | Measured per 2 hour time period after consuming 5 mL/kg of liquid | 
| Repeat ED visit |  | 72 hours | 
| Time (in minutes) from initiation of IV rehydration until disposition determination |  | Determined by outcome | 
| Attending physician discharge comfort level |  | Two and four hours following initiation of IV rehydration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pediatrics, Gastroenteritis, Dehydration, IV Rehydration