NIH-funded research R01 grant

Hyperhydration to protect kidneys in children with Shiga toxin 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-11404923 · Data updated 2026-11-12

A multinational study will test whether giving extra fluids early can reduce kidney injury and serious complications in children with Shiga toxin–producing E. coli infection.

Quick facts

Grant typeR01 grant
Study typeNIH-funded research
Funding institutionUniversity of Calgary
NIH-funded
Lab location1 site (Calgary, Canada)
Project startSeptember 17, 2021
Project endAugust 31, 2027
Funding year2026
Award (this year)$1,473,446
NIH project number5R01AI165327-06
Project IDNIH-11404923 on NIH RePORTER

Who could benefit from this research

Could help

Ideal candidates are children under 12 with STEC infection at participating centers and no contraindications to rapid fluid administration.

Less likely to help

Some children may not benefit if they have conditions that make hyperhydration unsafe or if they do not develop kidney involvement.

What this research studies

This trial focuses on children 0–11 years old who have a high-risk STEC infection. Children with early signs of kidney trouble will be randomly assigned to receive either aggressive fluid treatment or standard fluid care, in a crossover cluster design across sites. The goal is to see if early hyperhydration lowers the risk of major kidney events and other serious problems within 30 days, while also monitoring safety. Researchers will collect clinical data and biospecimens to understand how fluids affect kidney recovery and inflammation.

Why it matters

Potential benefit: If successful, children with STEC infection could have fewer kidney complications and better short-term outcomes.

How similar studies have gone: Prior observational data suggested potential benefit of early fluid support, but randomized trial evidence is lacking; this study aims to provide definitive answers.

Where this research is happening

  • University of Calgary
    Calgary, Canada
    Active

Researchers

  • Principal investigator: Freedman, Stephen Bradley — University of Calgary
  • Study coordinator: Freedman, Stephen Bradley

Related research

Other NIH-funded projects on the same topics.

About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.