Clinical trial NCT00392145: Emergency Department Rapid Intravenous Rehydration (RIVR) for Pediatric Gastroenteritis
Official title: Emergency Department Rapid Intravenous Rehydration (RIVR) for Pediatric Gastroenteritis: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gastroenteritis
Dehydration
Keywords: Pediatrics
Gastroenteritis
Dehydration
IV Rehydration
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: The Physicians' Services Incorporated Foundation
First posted: 2006-10-25
Enrollment: 226
Sex: ALL
Minimum age (years): 90
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Rehydration criteria defined by: dehydration score ≤ 1, normal capillary refill time, normal skin turgor, normal respiratory rate
timeFrame: 2 hours following the initiation of IV rehydration
Secondary outcomes:
measure: Hospitalization
timeFrame: 72 hours
measure: Ability to tolerate oral rehydration
timeFrame: Measured per 2 hour time period after consuming 5 mL/kg of liquid
measure: Repeat ED visit
timeFrame: 72 hours
measure: Time (in minutes) from initiation of IV rehydration until disposition determination
timeFrame: Determined by outcome
measure: Attending physician discharge comfort level
timeFrame: Two and four hours following initiation of IV rehydration
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children, Toronto Canada
name: Stephen B Freedman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Freedman SB, DeGroot JM, Parkin PC. Successful discharge of children with gastroenteritis requiring intravenous rehydration. J Emerg Med. 2014 Jan;46(1):9-20. doi: 10.1016/j.jemermed.2013.04.044. Epub 2013 Aug 30.
citation: Freedman SB, Parkin PC, Willan AR, Schuh S. Rapid versus standard intravenous rehydration in paediatric gastroenteritis: pragmatic blinded randomised clinical trial. BMJ. 2011 Nov 17;343:d6976. doi: 10.1136/bmj.d6976.