RecruitingNot ApplicableNCT05219110

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

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


Sponsor

University of Calgary

Enrollment

1,040 participants

Start Date

Sep 29, 2022

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 9 MonthsMax Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Infusion of 200% maintenance fluids as balanced crystalloid IV solution and Oral fluids; infusion of up to 110% maintenance fluids as balanced crystalloid IV solution for people with hemolytic-uremic syndrome and shiga toxin-producing escherichia coli (e. coli) infection. The study is currently recruiting participants at 26 locations. People eligible for this study include aged 9 Months to 21 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERInfusion 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.

OTHEROral 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

View Full Details on ClinicalTrials.gov

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NCT05219110


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