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Completed

NCT Number: NCT00392145

Emergency Department Rapid Intravenous Rehydration (RIVR) for Pediatric Gastroenteritis

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.

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Key information

Age range

90 day–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard IV rehydration

Drug

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)

Drug

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).

Primary outcomes

  1. 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

Secondary outcomes

  1. Hospitalization

    Time frame: 72 hours

  2. Ability to tolerate oral rehydration

    Time frame: Measured per 2 hour time period after consuming 5 mL/kg of liquid

  3. Repeat ED visit

    Time frame: 72 hours

  4. Time (in minutes) from initiation of IV rehydration until disposition determination

    Time frame: Determined by outcome

  5. Attending physician discharge comfort level

    Time frame: Two and four hours following initiation of IV rehydration

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Collaborators

  • The Physicians' Services Incorporated Foundation

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Oct 25, 2006
Registry last updated
Apr 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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