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RECRUITING
NCT05219110
NA

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

Sponsor: University of Calgary

View on ClinicalTrials.gov

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).

Official title: Hyperhydration to Improve Kidney Outcomes in Children With Shiga Toxin-Producing E. Coli Infection: A Multinational Embedded Cluster Crossover Randomized Trial

Key Details

Gender

All

Age Range

9 Months - 21 Years

Study Type

INTERVENTIONAL

Enrollment

1040

Start Date

2022-09-29

Completion Date

2027-08-31

Last Updated

2025-06-05

Healthy Volunteers

No

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.

Locations (26)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Arkansas Children's Hospital

Little Rock, Arkansas, United States

University of California, San Diego

La Jolla, California, United States

University of California, Davis

Sacramento, California, United States

University of Colorado Denver

Denver, Colorado, United States

Children's Research Institute

Washington D.C., District of Columbia, United States

Emory University

Atlanta, Georgia, United States

Indiana University Children's Hospital

Indianapolis, Indiana, United States

University of Kentucky

Lexington, Kentucky, United States

Norton Children's Hospital

Louisville, Kentucky, United States

Children's Minnesota Hospital

Minneapolis, Minnesota, United States

Washington University

St Louis, Missouri, United States

Children's Hospital Medical Center

Cincinnati, Ohio, United States

University Hospitals Rainbow Babies & Children's Hospital

Cleveland, Ohio, United States

Nationwide Children's Hospital

Columbus, Ohio, United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Oregon Health & Science University

Portland, Oregon, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Vanderbilt Children's Hospital

Nashville, Tennessee, United States

Baylor College of Medicine

Houston, Texas, United States

University of Utah

Salt Lake City, Utah, United States

Seattle Children's Hospital

Seattle, Washington, United States

Alberta Children's Hospital

Calgary, Alberta, Canada

University of Alberta

Edmonton, Alberta, Canada

McMaster University

Hamilton, Ontario, Canada

The Hospital for Sick Children

Toronto, Ontario, Canada