Emergency Department Rapid Intravenous Rehydration (RIVR) for Pediatric Gastroenteritis

This study has been completed.
Sponsor:
Collaborator:
The Physicians' Services Incorporated Foundation
Information provided by (Responsible Party):
Stephen Freedman, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT00392145
First received: June 27, 2006
Last updated: December 10, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Gastroenteritis
Dehydration
Drug: Standard IV rehydration
Drug: Rapid intravenous rehydration (RIVR)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Emergency Department Rapid Intravenous Rehydration (RIVR) for Pediatric Gastroenteritis: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hospitalization [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
  • Ability to tolerate oral rehydration [ Time Frame: Measured per 2 hour time period after consuming 5 mL/kg of liquid ] [ Designated as safety issue: No ]
  • Repeat ED visit [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
  • Time (in minutes) from initiation of IV rehydration until disposition determination [ Time Frame: Determined by outcome ] [ Designated as safety issue: No ]
  • Attending physician discharge comfort level [ Time Frame: Two and four hours following initiation of IV rehydration ] [ Designated as safety issue: No ]

Enrollment: 226
Study Start Date: November 2006
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
Experimental: 2 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).

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

Ages Eligible for Study:   90 Days to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00392145

Locations
Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
The Hospital for Sick Children
The Physicians' Services Incorporated Foundation
Investigators
Principal Investigator: Stephen B Freedman, MD The Hospital for Sick Children, Toronto Canada
  More Information

No publications provided by The Hospital for Sick Children

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Stephen Freedman, Adjunct Scientist, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT00392145     History of Changes
Other Study ID Numbers: 1000008579
Study First Received: June 27, 2006
Last Updated: December 10, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by The Hospital for Sick Children:
Pediatrics
Gastroenteritis
Dehydration
IV Rehydration

Additional relevant MeSH terms:
Dehydration
Gastroenteritis
Digestive System Diseases
Gastrointestinal Diseases
Metabolic Diseases
Pathologic Processes
Water-Electrolyte Imbalance

ClinicalTrials.gov processed this record on October 23, 2014