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Emergency Department Rapid Intravenous Rehydration (RIVR) for Pediatric Gastroenteritis

Primary Purpose

Gastroenteritis, Dehydration

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Standard IV rehydration
Rapid intravenous rehydration (RIVR)
Sponsored by
The Hospital for Sick Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroenteritis focused on measuring Pediatrics, Gastroenteritis, Dehydration, IV Rehydration

Eligibility Criteria

90 Days - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Hospital for Sick Children

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Rehydration criteria defined by: dehydration score ≤ 1, normal capillary refill time, normal skin turgor, normal respiratory rate

Secondary Outcome Measures

Hospitalization
Ability to tolerate oral rehydration
Repeat ED visit
Time (in minutes) from initiation of IV rehydration until disposition determination
Attending physician discharge comfort level

Full Information

First Posted
June 27, 2006
Last Updated
April 16, 2018
Sponsor
The Hospital for Sick Children
Collaborators
The Physicians' Services Incorporated Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00392145
Brief Title
Emergency Department Rapid Intravenous Rehydration (RIVR) for Pediatric Gastroenteritis
Official Title
Emergency Department Rapid Intravenous Rehydration (RIVR) for Pediatric Gastroenteritis: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children
Collaborators
The Physicians' Services Incorporated Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroenteritis, Dehydration
Keywords
Pediatrics, Gastroenteritis, Dehydration, IV Rehydration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
226 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Standard IV rehydration
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Rapid intravenous rehydration (RIVR)
Intervention Description
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).
Primary Outcome Measure Information:
Title
Rehydration criteria defined by: dehydration score ≤ 1, normal capillary refill time, normal skin turgor, normal respiratory rate
Time Frame
2 hours following the initiation of IV rehydration
Secondary Outcome Measure Information:
Title
Hospitalization
Time Frame
72 hours
Title
Ability to tolerate oral rehydration
Time Frame
Measured per 2 hour time period after consuming 5 mL/kg of liquid
Title
Repeat ED visit
Time Frame
72 hours
Title
Time (in minutes) from initiation of IV rehydration until disposition determination
Time Frame
Determined by outcome
Title
Attending physician discharge comfort level
Time Frame
Two and four hours following initiation of IV rehydration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
90 Days
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen B Freedman, MD
Organizational Affiliation
The Hospital for Sick Children, Toronto Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
23993936
Citation
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.
Results Reference
derived
PubMed Identifier
22094316
Citation
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.
Results Reference
derived

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Emergency Department Rapid Intravenous Rehydration (RIVR) for Pediatric Gastroenteritis

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