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High volume fluid treatment for children with E. coli infection

Hyperhydration to Improve Kidney Outcomes in Children With Shiga Toxin-Producing E. Coli Infection: A Multinational Embedded Cluster Crossover Randomized Trial

Not applicable Interventional University of Calgary · NCT05219110

This study is testing if giving children with a serious E. coli infection more fluids through an IV can help prevent kidney problems and other complications.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment1040 (estimated)
Ages9 Months to 21 Years
SexAll
SponsorUniversity of Calgary Academic / other
Locations26 sites (Birmingham, Alabama and 25 other locations)
Trial IDNCT05219110 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness of early high volume intravenous fluid administration, known as hyperhydration, in preventing complications from Shiga toxin-producing E. coli (STEC) infection in children and adolescents. It compares this approach to traditional conservative fluid management strategies. The study focuses on children aged 9 months to under 21 years who show signs of high-risk STEC infection, with the goal of improving renal outcomes and reducing the incidence of hemolytic uremic syndrome (HUS). Participants will receive a specific infusion of balanced crystalloid IV solutions as part of the intervention.

Who should consider this trial

Good fit: Ideal candidates for this study are children aged 9 months to under 21 years with evidence of high-risk STEC infection.

Not a fit: Patients who do not have a confirmed or presumptive diagnosis of high-risk STEC infection may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the risk of kidney injury and other complications in children suffering from STEC infections.

How similar studies have performed: Previous studies on similar interventions have not shown benefits, making this approach relatively novel and untested.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Birmingham, Alabama and 25 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Shiga Toxin-Producing Escherichia Coli InfectionHemolytic-Uremic SyndromeChildHemolytic Uremic SyndromeShiga-Toxigenic Escherichia coliRenal Replacement TherapyAcute Kidney InjuryAmbulatory Care
Last reviewed 2026-06-13 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.