Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Clinical Trials in Canada / NCT05219110
Recruiting Not applicable

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

NCT05219110 · tracked via the Priya Life Science Canada tracker
Phase
Not applicable
Started
2022-09-29
Last updated
2026-05-18

Condition(s) studied

Shiga Toxin-Producing Escherichia Coli (E. Coli) InfectionHemolytic-Uremic Syndrome

Investigational drug(s) / intervention(s)

Infusion of 200% maintenance fluids as balanced crystalloid IV solutionOral fluids; infusion of up to 110% maintenance fluids as balanced crystalloid IV solution

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.

Study 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

Sex
ALL
Min age
9 Months
Max age
21 Years
Healthy volunteers
No
Inclusion Criteria: In order to be eligible to participate in this study (i.e., to be enrolled in the relevant institutional clinical care pathway), an individual must meet all of the following criteria: 1. Aged 9.0 months to \<21 years at the time of informed consent. 2. Evidence of high-risk STEC infecting pathogen defined by any of the following: 1. Bloody diarrhea within the preceding 7 days * Positive STEC culture OR * Positive antigen/polymerase chain reaction test for toxin/gene type not otherwise specified OR 2. Bloody or Non-bloody diarrhea within the preceding 7 days •Presumptive diagnosis of HUS * (meeting all 3 HUS criteria - anemia, thrombocytopenia, and renal insufficiency) OR 3. Non-bloody or no diarrhea * Positive STEC culture for high-risk strain (i.e., O103, O104, O111, O113, O121, O145 or O157) OR * Positive antigen/polymerase chain reaction test Stx2 toxin/gene Exclusion Criteria: All individuals meeting any of the exclusion criteria at baseline will be excluded from study participation. 1. Presence of Advanced HUS defined by: 1. Hematocrit \<30% AND 2. Platelet count \<150 x 103/mm3 AND 3. Creatinine \> 2.0 mg/dL (177 µmol/L) * The presence of only 1 or 2 of these criteria will not result in patient exclusion, regardless of how close the 3rd criterion is to meeting the exclusion criteria. 2. Prior episode of HUS or diagnosis of atypical HUS. 3. Chronic disease limiting fluid volumes administered (e.g. impaired renal, liver, or cardiac function, chronic lung disease). 4. Evidence of anuria (i.e., no urine output for \> 24 hours). 5. Hypoxemia requiring oxygen therapy 6. Hypertensive emergency 7. Greater than or equal to 10 days since onset of diarrhea or if no diarrhea then the onset of other symptoms. 8. Patients with known pregnancy 9. Patients or caregivers with language barriers impairing appropriate conduct of the study protocol.

Primary outcome measure(s)

Trial sites (26)

FacilityCityRegionStatus
University of Alabama at Birmingham Birmingham Alabama Recruiting
Arkansas Children's Hospital Little Rock Arkansas Recruiting
University of California, San Diego La Jolla California Recruiting
University of California, Davis Sacramento California Recruiting
University of Colorado Denver Denver Colorado Recruiting
Children's Research Institute Washington D.C. District of Columbia Recruiting
Emory University Atlanta Georgia Recruiting
Indiana University Children's Hospital Indianapolis Indiana Recruiting
University of Kentucky Lexington Kentucky Recruiting
Norton Children's Hospital Louisville Kentucky Recruiting
Children's Minnesota Hospital Minneapolis Minnesota Recruiting
Washington University St Louis Missouri Recruiting
Children's Hospital Medical Center Cincinnati Ohio Recruiting
University Hospitals Rainbow Babies & Children's Hospital Cleveland Ohio Recruiting
Nationwide Children's Hospital Columbus Ohio Recruiting
University of Oklahoma Health Sciences Center Oklahoma City Oklahoma Recruiting
Oregon Health & Science University Portland Oregon Recruiting
Medical University of South Carolina Charleston South Carolina Recruiting
Vanderbilt Children's Hospital Nashville Tennessee Recruiting
Baylor College of Medicine Houston Texas Recruiting
University of Utah Salt Lake City Utah Recruiting
Seattle Children's Hospital Seattle Washington Recruiting
Alberta Children's Hospital Calgary Alberta Recruiting
University of Alberta Edmonton Alberta Recruiting
McMaster University Hamilton Ontario Recruiting
The Hospital for Sick Children Toronto Ontario Recruiting

More University of Calgary trials in Canada

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05219110 on ClinicalTrials.gov ↗ ← All trials in Canada