Emergency Department Rapid Intravenous Rehydration (RIVR) for Pediatric Gastroenteritis

Dehydration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00392145
• Other study ID #: 1000008579
• Status: Completed
• Phase: Phase 4
• First received: June 27, 2006
• Last updated: April 16, 2018
• Start date: November 2006
• Est. completion date: May 2010

Study information

• Verified date: April 2018
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 226
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 90 Days to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Dehydration
• Emergencies
• Gastroenteritis

Intervention

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).
• 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).

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
The Hospital for Sick Children	The Physicians' Services Incorporated Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rehydration criteria defined by: dehydration score = 1, normal capillary refill time, normal skin turgor, normal respiratory rate		2 hours following the initiation of IV rehydration
Secondary	Hospitalization		72 hours
Secondary	Ability to tolerate oral rehydration		Measured per 2 hour time period after consuming 5 mL/kg of liquid
Secondary	Repeat ED visit		72 hours
Secondary	Time (in minutes) from initiation of IV rehydration until disposition determination		Determined by outcome
Secondary	Attending physician discharge comfort level		Two and four hours following initiation of IV rehydration