Emergency Department Rapid Intravenous Rehydration (RIVR) for Pediatric Gastroenteritis - Full Text View

Sponsors and Collaborators:	The Hospital for Sick Children The Physicians' Services Incorporated Foundation
Information provided by:	The Hospital for Sick Children
ClinicalTrials.gov Identifier:	NCT00392145

Purpose

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.

Condition	Intervention	Phase
Gastroenteritis Dehydration	Drug: Standard IV rehydration Drug: Rapid intravenous rehydration (RIVR)	Phase IV

MedlinePlus related topics: Gastroenteritis

Drug Information available for: Sodium chloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Emergency Department Rapid Intravenous Rehydration (RIVR) for Pediatric Gastroenteritis: A Randomized Controlled Trial

Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Hospitalization [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
Ability to tolerate oral rehydration [ Time Frame: Measured per 2 hour time period after consuming 5 mL/kg of liquid ] [ Designated as safety issue: No ]
Repeat ED visit [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
Time (in minutes) from initiation of IV rehydration until disposition determination [ Time Frame: Determined by outcome ] [ Designated as safety issue: No ]
Attending physician discharge comfort level [ Time Frame: Two and four hours following initiation of IV rehydration ] [ Designated as safety issue: No ]

Estimated Enrollment:	226
Study Start Date:	November 2006
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	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).
2: Experimental	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).

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.

Eligibility

Ages Eligible for Study:	90 Days to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00392145

Contacts

Contact: Stephen B Freedman, MD

416-813-2382

stephen.freedman@sickkids.ca

Locations

Canada, Ontario
The Hospital for Sick Children	Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Stephen B Freedman, MD 416 813 2382 stephen.freedman@sickkids.ca
Principal Investigator: Stephen B Freedman, MD
Sub-Investigator: Patricia Parkin, MD
Sub-Investigator: Andrew R Willan, PhD
Sub-Investigator: Suzanne Schuh, MD

Sponsors and Collaborators

The Hospital for Sick Children

The Physicians' Services Incorporated Foundation

Investigators

Principal Investigator:

Stephen B Freedman, MD

The Hospital for Sick Children, Toronto Canada

More Information

Responsible Party:	The Hospital for Sick Children ( Stephen Freedman/Principal Investigator )
Study ID Numbers:	1000008579
Study First Received:	June 27, 2006
Last Updated:	June 2, 2008
ClinicalTrials.gov Identifier:	NCT00392145
Health Authority:	Canada: Ethics Review Committee

Keywords provided by The Hospital for Sick Children:

Pediatrics
Gastroenteritis
Dehydration
IV Rehydration

Study placed in the following topic categories:

Digestive System Diseases
Metabolic Diseases
Gastrointestinal Diseases
Emergencies

Water-Electrolyte Imbalance
Metabolic disorder
Gastroenteritis
Dehydration

Additional relevant MeSH terms:

Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on January 14, 2009