NCT00392145

Emergency Department Rapid Intravenous Rehydration (RIVR) for Pediatric Gastroenteritis

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 226 (actual)
• Sponsor: The Hospital for Sick Children · Academic / Other
• Sex: All
• Age: 90 Days – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gastroenteritis
• Dehydration

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2006-11-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2006-10-25
• Last updated: 2018-04-17

Locations

1 site across 1 country: Canada