Interventions for preventing diarrhoea-associated haemolytic uraemic syndrome.
Aamer Imdad, John R Nelson, Emily E Tanner-Smith...
https://pubmed.ncbi.nlm.nih.gov/40277027Actively Recruiting
Phase Not Applicable
Age: 9Months - 21Years
All Genders
ID05219110
Hyperhydration to Improve Kidney Outcomes in Children With Shiga Toxin-Producing E. Coli Infection: A Multinational Embedded Cluster Crossover Randomized Trial
Led by University of Calgary · Updated on 2026-05-18
1040
Participants Needed
26
Research Sites
52 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
Researchers are evaluating whether early, high-volume intravenous fluid administration (hyperhydration) can help reduce or prevent complications in children and adolescents infected with shiga toxin-producing Escherichia coli (STEC), compared to traditional conservative fluid management. The study focuses on hemolytic uremic syndrome (HUS), a serious complication of STEC infection that can cause acute kidney injury and other life-threatening effects. Despite low mortality, many affected children face long-term health issues, and previous trials have not proven effective treatments since 1999. Participants are randomly assigned to one of two groups. The hyperhydration group receives intravenous fluids at 200% of maintenance for 24 hours, with adjustments based on hematocrit levels and weight gain, alongside allowed oral fluids. The conservative group follows current local practices, with fluid management decided by the clinical care team and admission based on specific lab evidence. This study also establishes a biorepository to explore biomarkers and potential treatments. During the study, children are admitted for monitoring and receive fluid therapy according to their assigned group. Researchers assess kidney outcomes and serious complications over 30 days, focusing on major adverse kidney events including death, need for renal replacement therapy, or sustained kidney function loss. Safety and kidney health are closely monitored, with outcomes informing future care. The total participation time includes the initial treatment period and 30-day follow-up for outcome evaluation.
CONDITIONS
Brief Title
Hyperhydration in Children With Shiga Toxin-Producing E. Coli Infection
Who Can Participate
Age: 9Months - 21Years
All Genders
Eligibility Criteria
You may qualify if you...
- Aged 9.0 months to less than 21 years at the time of consent
- Evidence of high-risk shiga toxin-producing E. coli infection defined by either bloody diarrhea within 7 days with positive STEC test, or presumptive hemolytic uremic syndrome with anemia, thrombocytopenia, and renal insufficiency, or positive STEC culture or toxin gene test for high-risk strains
You will not qualify if you...
- Presence of advanced hemolytic uremic syndrome (hematocrit less than 30%, platelet count less than 150 x 10^3/mm3, and creatinine over 2.0 mg/dL)
- Prior episode of hemolytic uremic syndrome or diagnosis of atypical HUS
- Chronic disease limiting fluid volumes such as kidney, liver, heart, or lung disease
- No urine output for more than 24 hours (anuria)
- Hypoxemia requiring oxygen therapy
- Hypertensive emergency
- Diarrhea onset 10 days or more ago, or symptom onset over 10 days ago if no diarrhea
- Known pregnancy
- Language barriers impairing study conduct
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 30 days
Participants receive either hyperhydration with intravenous fluids or conservative fluid management to assess effects on kidney outcomes and complications.
Hospital admission and fluid administration with ongoing monitoring during treatment
Follow-up
Duration - Up to 30 days after treatment
Participants are monitored for major adverse kidney events and extrarenal complications through 30 days after treatment.
Follow-up visits as per clinical care
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
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Research Team
S
Study Manager
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Hyperhydration to Improve Kidney Outcomes in Children with Shiga Toxin-Producing E. coli Infection: a multinational embedded cluster crossover randomized trial (the HIKO STEC trial).
Stephen B Freedman, David Schnadower, Myka Estes...
https://pubmed.ncbi.nlm.nih.gov/37245030