Emergency Department Rapid Intravenous Rehydration (RIVR) for Pediatric Gastroenteritis
|ClinicalTrials.gov Identifier: NCT00392145|
Recruitment Status : Completed
First Posted : October 25, 2006
Last Update Posted : December 11, 2013
|Condition or disease||Intervention/treatment||Phase|
|Gastroenteritis Dehydration||Drug: Standard IV rehydration Drug: Rapid intravenous rehydration (RIVR)||Phase 4|
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 (Clinical Trial)|
|Actual Enrollment :||226 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Emergency Department Rapid Intravenous Rehydration (RIVR) for Pediatric Gastroenteritis: A Randomized Controlled Trial|
|Study Start Date :||November 2006|
|Primary Completion Date :||May 2010|
|Study Completion Date :||May 2010|
|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).
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).
- 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 ]
- Hospitalization [ Time Frame: 72 hours ]
- Ability to tolerate oral rehydration [ Time Frame: Measured per 2 hour time period after consuming 5 mL/kg of liquid ]
- Repeat ED visit [ Time Frame: 72 hours ]
- Time (in minutes) from initiation of IV rehydration until disposition determination [ Time Frame: Determined by outcome ]
- Attending physician discharge comfort level [ Time Frame: Two and four hours following initiation of IV rehydration ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00392145
|The Hospital for Sick Children|
|Toronto, Ontario, Canada, M5G 1X8|
|Principal Investigator:||Stephen B Freedman, MD||The Hospital for Sick Children, Toronto Canada|