Hyperhydration in Children With Shiga Toxin-Producing E. Coli Infection

Summary

The objective of this study is to determine if early high volume intravenous fluid administration (hyperhydration) may be effective in mitigating or preventing complications of shiga toxin-producing E. coli (STEC) infection in children and adolescents when compared with traditional approaches (conservative fluid management).

Conditions

• Shiga Toxin-Producing Escherichia Coli (E. Coli) Infection
• Hemolytic-Uremic Syndrome

Interventions

OTHER

Infusion of 200% maintenance fluids as balanced crystalloid IV solution

Infusion of 200% of maintenance fluids x 24 hours provided, ideally, as a balanced crystalloid (PlasmaLyteTM, Ringer's Lactate) IV solution. Electrolytes and dextrose may be administered as required and desired by the clinical care team; customized solutions are permitted if so desired. Intravenous fluid solutions containing \< 130 mEq/L sodium may increase risk for hyponatremia and may be less effective in achieving intravascular volume expansion and should be avoided.

OTHER

Oral fluids; infusion of up to 110% maintenance fluids as balanced crystalloid IV solution

Administration of less than or equal to 110% of maintenance fluids as oral or balanced crystalloid IV solution.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID)

  collaborator NIH

• Children's Hospital Medical Center, Cincinnati

  collaborator OTHER

• Washington University School of Medicine

  collaborator OTHER

• University of Utah

  collaborator OTHER

• Seattle Children's Hospital

  collaborator OTHER

• University of Colorado, Denver

  collaborator OTHER

• Emory University

  collaborator OTHER

• University of California, Davis

  collaborator OTHER

• Baylor College of Medicine

  collaborator OTHER

• Indiana University

  collaborator OTHER

• University of Alabama at Birmingham

  collaborator OTHER

• Arkansas Children's Hospital Research Institute

  collaborator OTHER

• Children's National Research Institute

  collaborator OTHER

• Children's Hospitals and Clinics of Minnesota

  collaborator OTHER

• Medical University of South Carolina

  collaborator OTHER

• University of Louisville

  collaborator OTHER

• University of Oklahoma

  collaborator OTHER

• Oregon Health and Science University

  collaborator OTHER

• University of California, San Diego

  collaborator OTHER

• McMaster University

  collaborator OTHER

• The Hospital for Sick Children

  collaborator OTHER

• University of Alberta

  collaborator OTHER

• University of Kentucky

  collaborator OTHER

• Case Western Reserve University

  collaborator OTHER

• Nationwide Children's Hospital

  collaborator OTHER

• Vanderbilt University Medical Center

  collaborator OTHER

• University of Calgary

  lead OTHER

Principal Investigators

• Stephen Freedman, MDCM · University of Calgary

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

9 Months

Max Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-09-29

Primary Completion

2027-08-31

Completion

2028-08-31

Countries

• United States
• Canada

Study Locations