Emergency Department Rapid Intravenous Rehydration (RIVR) for Pediatric Gastroenteritis

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

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.

Study Overview

• Status: Completed
• Conditions: Gastroenteritis; Dehydration
• Intervention / Treatment: Drug: Standard IV rehydration; Drug: Rapid intravenous rehydration (RIVR)

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 Type: Interventional
• Enrollment (Actual): 226
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X8
      • The Hospital for Sick Children

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 months to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 2	Drug: Rapid intravenous rehydration (RIVR); 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).
Active Comparator: 1	Drug: Standard IV rehydration; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: The Hospital for Sick Children
• Collaborators: The Physicians' Services Incorporated Foundation
• Investigators: Principal Investigator: Stephen B Freedman, MD, The Hospital for Sick Children, Toronto Canada

Publications and helpful links

General Publications

• Freedman SB, DeGroot JM, Parkin PC. Successful discharge of children with gastroenteritis requiring intravenous rehydration. J Emerg Med. 2014 Jan;46(1):9-20. doi: 10.1016/j.jemermed.2013.04.044. Epub 2013 Aug 30.
• Freedman SB, Parkin PC, Willan AR, Schuh S. Rapid versus standard intravenous rehydration in paediatric gastroenteritis: pragmatic blinded randomised clinical trial. BMJ. 2011 Nov 17;343:d6976. doi: 10.1136/bmj.d6976.

Study record dates

Study Major Dates

• Study Start: November 1, 2006
• Primary Completion (Actual): May 1, 2010
• Study Completion (Actual): May 1, 2010

Study Registration Dates

• First Submitted: June 27, 2006
• First Submitted That Met QC Criteria: October 23, 2006
• First Posted (Estimate): October 25, 2006

Study Record Updates

• Last Update Posted (Actual): April 17, 2018
• Last Update Submitted That Met QC Criteria: April 16, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Gastroenteritis; Dehydration; Pediatrics; IV Rehydration
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Metabolic Diseases; Disease Attributes; Gastrointestinal Diseases; Water-Electrolyte Imbalance; Emergencies; Gastroenteritis; Dehydration
• Other Study ID Numbers: 1000008579