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Hyperhydration in Children With Shiga Toxin-Producing E. Coli Infection
Sponsor: University of Calgary
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
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.
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