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

Recruiting now · Not applicable

Conditions studied: Shiga Toxin-Producing Escherichia Coli (E. Coli) Infection, Hemolytic-Uremic Syndrome

In brief

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).

Key facts

Study ID

NCT05219110

Run by

University of Calgary

People needed

1040

Starts

2022-09-29

Expected to finish

2028-08-31

Last updated by the study team

2026-05-18

Who can join

Age: 1 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• 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
• Positive STEC culture OR
• Positive antigen/polymerase chain reaction test for toxin/gene type not otherwise specified OR
• 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
• 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

You may not qualify if…

• All individuals meeting any of the exclusion criteria at baseline will be excluded from study participation.
• Presence of Advanced HUS defined by:
• Hematocrit <30% AND
• Platelet count <150 x 103/mm3 AND
• 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.
• 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
• Hypertensive emergency
• Greater than or equal to 10 days since onset of diarrhea or if no diarrhea then the onset of other symptoms.
• Patients with known pregnancy
• Patients or caregivers with language barriers impairing appropriate conduct of the study protocol.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States (enrolling)
• Arkansas Children's Hospital — Little Rock, Arkansas, United States (enrolling)
• University of California, San Diego — La Jolla, California, United States (enrolling)
• University of California, Davis — Sacramento, California, United States (enrolling)
• University of Colorado Denver — Denver, Colorado, United States (enrolling)
• Children's Research Institute — Washington D.C., District of Columbia, United States (enrolling)
• Emory University — Atlanta, Georgia, United States (enrolling)
• Indiana University Children's Hospital — Indianapolis, Indiana, United States (enrolling)
• University of Kentucky — Lexington, Kentucky, United States (enrolling)
• Norton Children's Hospital — Louisville, Kentucky, United States (enrolling)
• Children's Minnesota Hospital — Minneapolis, Minnesota, United States (enrolling)
• Washington University — St Louis, Missouri, United States (enrolling)
• Children's Hospital Medical Center — Cincinnati, Ohio, United States (enrolling)
• University Hospitals Rainbow Babies & Children's Hospital — Cleveland, Ohio, United States (enrolling)
• Nationwide Children's Hospital — Columbus, Ohio, United States (enrolling)
• University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States (enrolling)
• Oregon Health & Science University — Portland, Oregon, United States (enrolling)
• Medical University of South Carolina — Charleston, South Carolina, United States (enrolling)
• Vanderbilt Children's Hospital — Nashville, Tennessee, United States (enrolling)
• Baylor College of Medicine — Houston, Texas, United States (enrolling)
• University of Utah — Salt Lake City, Utah, United States (enrolling)
• Seattle Children's Hospital — Seattle, Washington, United States (enrolling)
• Alberta Children's Hospital — Calgary, Alberta, Canada (enrolling)
• University of Alberta — Edmonton, Alberta, Canada (enrolling)
• McMaster University — Hamilton, Ontario, Canada (enrolling)

Full record on ClinicalTrials.gov

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