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Hyperhydration in Children With Shiga Toxin-Producing E. Coli Infection
NCT05219110 · View on ClinicalTrials.gov ↗
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).
Conditions Studied
Interventions
- OTHER Infusion of 200% maintenance fluids as balanced crystalloid IV solution
- OTHER Oral fluids; infusion of up to 110% maintenance fluids as balanced crystalloid IV solution
Study Locations (20)
Ohio
- Children's Hospital Medical Center — Cincinnati
- University Hospitals Rainbow Babies & Children's Hospital — Cleveland
- Nationwide Children's Hospital — Columbus
California
- University of California, San Diego — La Jolla
- University of California, Davis — Sacramento
Kentucky
- University of Kentucky — Lexington
- Norton Children's Hospital — Louisville
Alabama
- University of Alabama at Birmingham — Birmingham
Arkansas
- Arkansas Children's Hospital — Little Rock
Colorado
- University of Colorado Denver — Denver
District of Columbia
- Children's Research Institute — Washington D.C.
Georgia
- Emory University — Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,040 participants |
| Start Date | 2022-09-29 |
| Est. Completion | 2027-08-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05219110
The ClinicalTrials.gov registry entry for NCT05219110 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,040 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Calgary, which has 64 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Shiga Toxin-Producing Escherichia Coli (E. Coli) Infection appearing as the primary indexed condition, and to 2 interventions — of which Infusion of 200% maintenance fluids as balanced crystalloid IV solution is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05219110 reports 20 study locations spanning 16 distinct geographic areas — top geographies include Ohio, California, Kentucky. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05219110 about?
NCT05219110 is a clinical study titled "Hyperhydration in Children With Shiga Toxin-Producing E. Coli Infection". 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 (conse...
What is the current status of trial NCT05219110?
This trial is currently recruiting. It is a NA study. The enrollment target is 1,040 participants. The study started on 2022-09-29. Estimated completion is 2027-08-31.
What conditions does trial NCT05219110 study?
This clinical trial studies the following conditions: Shiga Toxin-Producing Escherichia Coli (E. Coli) Infection, Hemolytic-Uremic Syndrome. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05219110?
The interventions under investigation include: Infusion of 200% maintenance fluids as balanced crystalloid IV solution (OTHER), Oral fluids; infusion of up to 110% maintenance fluids as balanced crystalloid IV solution (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05219110?
This trial is sponsored by University of Calgary, which has 64 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05219110 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Colorado, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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