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Hyperhydration in Children With Shiga Toxin-Producing E. Coli Infection
Hyperhydration to Improve Kidney Outcomes in Children With Shiga Toxin-Producing E. Coli Infection: A Multinational Embedded Cluster Crossover Randomized Trial
Who can join
9 Months – 21 Years · All sexes
Full eligibility 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.About the study
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).
What is being tested
- 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)
Sponsor: University of Calgary · Participants: 1,040 · Started: Sep 29, 2022
Contact the study team
- Study Manager · Phone: (801) 581-6410
Official record on ClinicalTrials.gov — NCT05219110
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.