RecruitingNot Applicable

Hyperhydration in Children With Shiga Toxin-Producing E. Coli Infection

United States1,040 participantsStarted 2022-09-29

Plain-language 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).

Who can participate

Age range9 Months – 21 Years

SexALL

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Inclusion criteria

✓. Aged 9.0 months to \<21 years at the time of informed consent.
✓. Evidence of high-risk STEC infecting pathogen defined by any of the following:
✓. Bloody diarrhea within the preceding 7 days
✓. Bloody or Non-bloody diarrhea within the preceding 7 days
✓. Non-bloody or no diarrhea

Exclusion criteria

✕. Presence of Advanced HUS defined by:
✕. Hematocrit \<30% AND
✕. Platelet count \<150 x 103/mm3 AND
✕. Creatinine \> 2.0 mg/dL (177 µmol/L)
✕. Prior episode of HUS or diagnosis of atypical HUS.
✕. Chronic disease limiting fluid volumes administered (e.g. impaired renal, liver, or cardiac function, chronic lung disease).
✕. Evidence of anuria (i.e., no urine output for \> 24 hours).
✕. Hypoxemia requiring oxygen therapy

What they're measuring

Major Adverse Kidney Events by 30 days (MAKE30)

Timeframe: 30 days

Trial details

NCT IDNCT05219110

SponsorUniversity of Calgary

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-08-31

Contact for this trial

Study Manager

(801) 581-6410 hikostec@hsc.utah.edu

View on ClinicalTrials.gov More Shiga Toxin-Producing Escherichia Coli (E. Coli) Infection trials