Sponsor:
University of Calgary
Code:
NCT05219110
Conditions
Shiga Toxin-Producing Escherichia Coli (E. Coli) Infection
Hemolytic-Uremic Syndrome
Eligibility Criteria
Sex: All
Age: 0 - 21
Healthy Volunteers: Not accepted
Interventions
Infusion of 200% maintenance fluids as balanced crystalloid IV solution
Oral fluids; infusion of up to 110% maintenance fluids as balanced crystalloid IV solution
Brief summary:
Conditions
Shiga Toxin-Producing Escherichia Coli (E. Coli) Infection
Hemolytic-Uremic Syndrome
Study ID
NCT05219110
Start date
Sep 29, 2022
Status verified date
May, 2026
Completion date
Aug 31, 2028
Anticipated
Primary completion date
Aug 31, 2027
Anticipated
Eligibility Criteria
Sex: All
Age: 0 - 21
Healthy Volunteers: Not accepted
Enrollment
1040 participants
Anticipated
Allocation
Randomized
Intervention Model
Crossover
Primary purpose
Treatment
Arms
experimental: Hyperhydration
active comparator: Conservative Fluid Management
Interventions
Infusion of 200% maintenance fluids as balanced crystalloid IV solution
Oral fluids; infusion of up to 110% maintenance fluids as balanced crystalloid IV solution
Primary outcome measure
Central contacts
Locations
University of Alabama at Birmingham
Recruiting
Birmingham, Alabama, United States, 35294
Arkansas Children's Hospital
Recruiting
Little Rock, Arkansas, United States, 72202
University of California, San Diego
Recruiting
La Jolla, California, United States, 92093
University of California, Davis
Recruiting
Sacramento, California, United States, 95817
University of Colorado Denver
Recruiting
Denver, Colorado, United States, 80045
Children's Research Institute
Recruiting
Washington D.C., District of Columbia, United States, 20010
Emory University
Recruiting
Atlanta, Georgia, United States, 30322
Indiana University Children's Hospital
Recruiting
Indianapolis, Indiana, United States, 47401
University of Kentucky
Recruiting
Lexington, Kentucky, United States, 40526
Norton Children's Hospital
Recruiting
Louisville, Kentucky, United States, 40202
Children's Minnesota Hospital
Recruiting
Minneapolis, Minnesota, United States, 55404
Washington University
Recruiting
St Louis, Missouri, United States, 63110
Children's Hospital Medical Center
Recruiting
Cincinnati, Ohio, United States, 45229-3039
University Hospitals Rainbow Babies & Children's Hospital
Recruiting
Cleveland, Ohio, United States, 44106
Nationwide Children's Hospital
Recruiting
Columbus, Ohio, United States, 43205
University of Oklahoma Health Sciences Center
Recruiting
Oklahoma City, Oklahoma, United States, 73104
Oregon Health & Science University
Recruiting
Portland, Oregon, United States, 97239
Medical University of South Carolina
Recruiting
Charleston, South Carolina, United States, 29425
Vanderbilt Children's Hospital
Recruiting
Nashville, Tennessee, United States, 43205
Baylor College of Medicine
Recruiting
Houston, Texas, United States, 77030
University of Utah
Recruiting
Salt Lake City, Utah, United States, 84112
Seattle Children's Hospital
Recruiting
Seattle, Washington, United States, 98105
Alberta Children's Hospital
Recruiting
Calgary, Alberta, Canada, T2N 1N4
University of Alberta
Recruiting
Edmonton, Alberta, Canada, T5J 4P6
McMaster University
Recruiting
Hamilton, Ontario, Canada, L8S 4K1
The Hospital for Sick Children
Recruiting
Toronto, Ontario, Canada, M5G 1X8
Sponsor
University of Calgary
Last update posted
May 18, 2026
Last verified
May, 2026
Keywords
Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Calgary on 2026-05-18.