Emergency Department Rapid Intravenous Rehydration (RIVR) for Pediatric Gastroenteritis

NCT ID: NCT00392145

Last Updated: 2018-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 226 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-11-30
• Study Completion Date: 2010-05-31

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.

Conditions

Gastroenteritis; Dehydration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

1

Group Type: ACTIVE_COMPARATOR

Standard IV rehydration

Intervention Type: 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).

2

Group Type: EXPERIMENTAL

Rapid intravenous rehydration (RIVR)

Intervention Type: 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).

Interventions

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).

Intervention Type: 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).

Intervention Type: DRUG

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

• Minimum Eligible Age: 90 Days
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Physicians' Services Incorporated Foundation

OTHER

Sponsor Role: collaborator

The Hospital for Sick Children

OTHER

Sponsor Role: lead

Responsible Party

Stephen Freedman

Adjunct Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephen B Freedman, MD

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children, Toronto Canada

Locations

The Hospital for Sick Children

Toronto, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 23993936 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 22094316 (View on PubMed)

Other Identifiers

1000008579

Identifier Type: -

Identifier Source: org_study_id