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

Recruiting

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

Sponsor: University of Calgary · Participants: 1,040 · Started: Sep 29, 2022

Contact the study team

Official record on ClinicalTrials.gov — NCT05219110

Locations in the U.S.

AlabamaUniversity of Alabama at Birmingham, Birmingham
ArkansasArkansas Children's Hospital, Little Rock
CaliforniaUniversity of California, San Diego, La Jolla
University of California, Davis, Sacramento
ColoradoUniversity of Colorado Denver, Denver
District of ColumbiaChildren's Research Institute, Washington D.C.
GeorgiaEmory University, Atlanta
IndianaIndiana University Children's Hospital, Indianapolis
KentuckyUniversity of Kentucky, Lexington
Norton Children's Hospital, Louisville
MinnesotaChildren's Minnesota Hospital, Minneapolis
MissouriWashington University, St Louis
OhioChildren's Hospital Medical Center, Cincinnati
University Hospitals Rainbow Babies & Children's Hospital, Cleveland
Nationwide Children's Hospital, Columbus
OklahomaUniversity of Oklahoma Health Sciences Center, Oklahoma City
OregonOregon Health & Science University, Portland
South CarolinaMedical University of South Carolina, Charleston
TennesseeVanderbilt Children's Hospital, Nashville
TexasBaylor College of Medicine, Houston
UtahUniversity of Utah, Salt Lake City
WashingtonSeattle Children's Hospital, Seattle

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.