Actively Recruiting
Hyperhydration in Children With Shiga Toxin-Producing E. Coli Infection
Led by University of Calgary · Updated on 2025-06-05
1040
Participants Needed
26
Research Sites
256 weeks
Total Duration
On this page
Sponsors
U
University of Calgary
Lead Sponsor
N
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Hyperhydration in Children With Shiga Toxin-Producing E. Coli Infection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 9 months to under 21 years at time of consent
- Evidence of high-risk STEC infection defined by either:
- Bloody diarrhea within past 7 days with positive STEC culture or toxin/gene test
- Bloody or non-bloody diarrhea within past 7 days with presumptive HUS diagnosis (anemia, thrombocytopenia, renal insufficiency)
- Non-bloody or no diarrhea with positive STEC culture for high-risk strain or positive Stx2 toxin/gene test
You will not qualify if you...
- Advanced HUS defined as hematocrit less than 30%, platelet count less than 150 x 10^3/mm3, and creatinine over 2.0 mg/dL
- Prior HUS episode or diagnosis of atypical HUS
- Chronic diseases limiting fluid administration (impaired kidney, liver, heart function, or chronic lung disease)
- Anuria (no urine output for over 24 hours)
- Hypoxemia requiring oxygen therapy
- Hypertensive emergency
- Diarrhea onset 10 or more days ago, or if no diarrhea, onset of other symptoms 10 or more days ago
- Known pregnancy
- Language barriers preventing proper study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 26 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Actively Recruiting
2
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
Actively Recruiting
3
University of California, San Diego
La Jolla, California, United States, 92093
Actively Recruiting
4
University of California, Davis
Sacramento, California, United States, 95817
Actively Recruiting
5
University of Colorado Denver
Denver, Colorado, United States, 80045
Actively Recruiting
6
Children's Research Institute
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
7
Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
8
Indiana University Children's Hospital
Indianapolis, Indiana, United States, 47401
Actively Recruiting
9
University of Kentucky
Lexington, Kentucky, United States, 40526
Actively Recruiting
10
Norton Children's Hospital
Louisville, Kentucky, United States, 40202
Actively Recruiting
11
Children's Minnesota Hospital
Minneapolis, Minnesota, United States, 55404
Actively Recruiting
12
Washington University
St Louis, Missouri, United States, 63110
Actively Recruiting
13
Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229-3039
Actively Recruiting
14
University Hospitals Rainbow Babies & Children's Hospital
Cleveland, Ohio, United States, 44106
Actively Recruiting
15
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Actively Recruiting
16
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
17
Oregon Health & Science University
Portland, Oregon, United States, 97239
Actively Recruiting
18
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
19
Vanderbilt Children's Hospital
Nashville, Tennessee, United States, 43205
Actively Recruiting
20
Baylor College of Medicine
Houston, Texas, United States, 77030
Actively Recruiting
21
University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
22
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Actively Recruiting
23
Alberta Children's Hospital
Calgary, Alberta, Canada, T2N 1N4
Actively Recruiting
24
University of Alberta
Edmonton, Alberta, Canada, T5J 4P6
Actively Recruiting
25
McMaster University
Hamilton, Ontario, Canada, L8S 4K1
Actively Recruiting
26
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Actively Recruiting
Research Team
S
Study Manager
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here