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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

June 27, 2006

Last Updated Date

June 2, 2008

Start Date ^†

November 2006

Current 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 ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00392145 on ClinicalTrials.gov Archive Site

Current 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 ]

Original Secondary Outcome Measures ^†

hospitalization
ability to tolerate oral rehydration
repeat ED visit within 72 hours
attending physician discharge comfort level

Descriptive Information

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

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 Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

Condition ^†

Gastroenteritis
Dehydration

Intervention ^†

Drug: Standard IV rehydration
Drug: Rapid intravenous rehydration (RIVR)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Estimated Enrollment ^†

226

Estimated Completion Date

June 2009

Estimated Primary Completion Date

June 2009 (final data collection date for primary outcome measure)

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

Gender

Both

Ages

90 Days to 18 Years

Accepts Healthy Volunteers

Contacts ^††

Contact: Stephen B Freedman, MD

416-813-2382

stephen.freedman@sickkids.ca

Location Countries ^†

Canada

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00392145

Responsible Party

Stephen Freedman/Principal Investigator, The Hospital for Sick Children

Secondary IDs ^††

Study 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

Information Provided By

The Hospital for Sick Children

Verification Date

June 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.