Early high-volume IV fluids to protect children's kidneys after E. coli infection
Official title: Hyperhydration to Improve Kidney Outcomes in Children with Shiga Toxin-Producing E. Coli Infection (HIKO STEC): A Multinational, Embedded, Cluster, Crossover, Randomized Trial
Funded at University of Calgary · NIH-11171689 · Data updated 2026-11-12
Giving extra IV fluids early to children with Shiga toxin–producing E. coli infection to help prevent kidney damage.
Quick facts
| Grant type | R01 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | University of Calgary NIH-funded |
| Lab location | 1 site (Calgary, Canada) |
| Project start | September 17, 2021 |
| Project end | August 31, 2027 |
| Funding year | 2025 |
| Award (this year) | $1,459,892 |
| NIH project number | 5R01AI165327-05 |
| Project ID | NIH-11171689 on NIH RePORTER |
Who could benefit from this research
✓Could help
Children (infants through about 11 years) who present to a participating emergency department or hospital with suspected or confirmed Shiga toxin–producing E. coli infection early in their illness.
✕Less likely to help
Children without STEC infection, those already in advanced HUS with established severe kidney failure, or those with medical reasons that make extra fluids unsafe (for example, heart failure) are unlikely to benefit from this approach.
What this research studies
If a child with suspected Shiga toxin–producing E. coli infection comes to a participating hospital, care teams in different hospitals and time periods will follow either an early aggressive IV fluid plan or the usual conservative fluid approach. Hospitals are randomized in a cluster, crossover design so sites switch between approaches over time, and children are treated according to the assigned approach when they present. Investigators will track whether early volume expansion lowers the chance of developing hemolytic uremic syndrome, needing dialysis, or having other serious complications, and will follow kidney health over time. The trial is multinational and embedded in routine emergency and hospital care so eligible children are enrolled when they present to participating centers.
Why it matters
Potential benefit: If successful, the approach could lower the risk of severe kidney injury, reduce the need for dialysis, and decrease long-term kidney problems in affected children.
How similar studies have gone: Only a few small randomized trials from decades ago showed no clear benefit, while recent observational studies suggest early hyperhydration might help but remain unproven in a large randomized trial.
Where this research is happening
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University of Calgary
Calgary, Canada Active
Researchers
- Principal investigator: Freedman, Stephen Bradley — University of Calgary
- Study coordinator: Freedman, Stephen Bradley
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.