Emergency Department Rapid Intravenous Rehydration (RIVR) for Pediatric Gastroenteritis

NCT00392145 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 226

Last updated 2018-04-17

No results posted yet for this study

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.

Conditions

Interventions

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).

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).

Sponsors & Collaborators

  • The Physicians' Services Incorporated Foundation

    collaborator OTHER
  • The Hospital for Sick Children

    lead OTHER

Principal Investigators

  • Stephen B Freedman, MD · The Hospital for Sick Children, Toronto Canada

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
90 Days
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-11-30
Primary Completion
2010-05-31
Completion
2010-05-31

Countries

  • Canada

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00392145 on ClinicalTrials.gov