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NCT05219110 · ClinicalTrials.gov registry record · NA
Hyperhydration in Children With Shiga Toxin-Producing E. Coli Infection
A NA study of Shiga Toxin-Producing Escherichia Coli (E. Coli) Infection and Hemolytic-Uremic Syndrome, sponsored by University of Calgary.
- Recruiting
- Registry status
- NA
- Development phase
- 1,040
- Enrollment target
- 20
- Study locations
NCT05219110: Recruiting NA study of Shiga Toxin-Producing Escherichia Coli (E. Coli) Infection and Hemolytic-Uremic Syndrome, sponsored by University of Calgary.
NCT05219110 is a NA study of Shiga Toxin-Producing Escherichia Coli (E. Coli) Infection and Hemolytic-Uremic Syndrome that is actively recruiting participants, run by University of Calgary. The registered enrollment target is 1,040 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (26% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05219110, a NA study of Shiga Toxin-Producing Escherichia Coli (E. Coli) Infection and Hemolytic-Uremic Syndrome, is actively recruiting participants, sponsored by University of Calgary.
- RECRUITING
- Registry status
- NA
- Development phase
- 1,040 participants
- Enrollment target
- 20
- Study locations
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).
Primary Outcome
1. Death due to any cause censored at 30 days after enrollment OR 2. Provision of RRT, any modality, within 30 days of trial enrollment OR 3. Sustained loss of kidney function (100% increase of serum sCr from baseline at 30±7 days)
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 |
What NCT05219110 shows while recruiting
NCT05219110 is an interventional study that assigns participants to a tested intervention. Its 1,040 participants enrollment target places it among the larger protocols in the corpus, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (26% lower).
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.
NCT05219110 names 20 study sites across 16 states, led by Ohio, California, Kentucky.
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.
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).
Who is sponsoring clinical trial NCT05219110?
This trial is sponsored by University of Calgary, which has 11 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05219110's enrollment target sits among peer trials
1,040 100th of 2000 higher than 1,901 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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