Emergency Department Rapid Intravenous Rehydration (RIVR) for Pediatric Gastroenteritis

Phase 4

Completed

• Conditions: Dehydration; Gastroenteritis
• Interventions: Drug: Standard IV rehydration; Drug: Rapid intravenous rehydration (RIVR)

• Registration Number: NCT00392145
• Lead Sponsor: The Hospital for Sick Children

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 receive rapid intravenous rehydration (RIVR) or in the children who receive standard IV rehydration.

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 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.

Study Timeline

• Study First Submitted: 2006-06-27
• Study First Submitted QC: 2006-10-23
• Study First Posted: 2006-10-25
• Study Start: 2006-11
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-16
• Last Update Posted: 2018-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 226

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Standard IV rehydration	-
2	Rapid intravenous rehydration (RIVR)	-

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada