High volume fluid treatment for children with E. coli infection

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University of Alabama at Birmingham
  Birmingham, Alabama, United States Recruiting
• Arkansas Children's Hospital
  Little Rock, Arkansas, United States Recruiting
• University of California, San Diego
  La Jolla, California, United States Recruiting
• University of California, Davis
  Sacramento, California, United States Recruiting
• University of Colorado Denver
  Denver, Colorado, United States Recruiting
• Children's Research Institute
  Washington D.C., District of Columbia, United States Recruiting

Study contacts

• Principal investigator: Stephen Freedman, MDCM — University of Calgary
• Study coordinator: Study Manager
• Email: hikostec@hsc.utah.edu
• Phone: (801) 581-6410

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.