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Hyperhydration in Children With Shiga Toxin-Producing E. Coli Infection
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).
Conditions:
🦠 Shiga Toxin-Producing Escherichia Coli (E. Coli) Infection 🦠 Hemolytic-Uremic Syndrome
🗓️ Study Start (Actual) 29 September 2022
🗓️ Primary Completion (Estimated) 31 August 2026
✅ Study Completion (Estimated) 31 August 2027
👥 Enrollment (Estimated) 1040
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE3
Locations:
📍 Birmingham, Alabama, United States
📍 Little Rock, Arkansas, United States
📍 La Jolla, California, United States
📍 Sacramento, California, United States
📍 Denver, Colorado, United States
📍 Washington, District of Columbia, United States
📍 Atlanta, Georgia, United States
📍 Indianapolis, Indiana, United States
📍 Lexington, Kentucky, United States
📍 Louisville, Kentucky, United States
📍 Minneapolis, Minnesota, United States
📍 Saint Louis, Missouri, United States
📍 Cincinnati, Ohio, United States
📍 Cleveland, Ohio, United States
📍 Columbus, Ohio, United States
📍 Oklahoma City, Oklahoma, United States
📍 Portland, Oregon, United States
📍 Charleston, South Carolina, United States
📍 Nashville, Tennessee, United States
📍 Houston, Texas, United States
📍 Salt Lake City, Utah, United States
📍 Seattle, Washington, United States
📍 Calgary, Alberta, Canada
📍 Edmonton, Alberta, Canada
📍 Hamilton, Ontario, Canada
📍 Toronto, Ontario, Canada
More locations available...

📋 Eligibility Criteria

Description

    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.
Ages Eligible for Study: 9 Months to 21 Years (CHILD, ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 20 January 2022
  • First Submitted that Met QC Criteria 20 January 2022
  • First Posted 1 February 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 21 July 2023
  • Last Update Posted 25 July 2023
  • Last Verified May 2023
I'm interested ...!!