RECRUITING

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

Description

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) InfectionHemolytic-Uremic Syndrome
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Related Conditions:

Shiga Toxin-Producing Escherichia Coli (E. Coli) InfectionHemolytic-Uremic Syndrome

Study Overview

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Study Details

Study overview

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).

Hyperhydration to Improve Kidney Outcomes in Children With Shiga Toxin-Producing E. Coli Infection: A Multinational Embedded Cluster Crossover Randomized Trial

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

Condition
Shiga Toxin-Producing Escherichia Coli (E. Coli) Infection
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama at Birmingham, Birmingham, Alabama, United States, 35294

Little Rock

Arkansas Children's Hospital, Little Rock, Arkansas, United States, 72202

La Jolla

University of California, San Diego, La Jolla, California, United States, 92093

Sacramento

University of California, Davis, Sacramento, California, United States, 95817

Denver

University of Colorado Denver, Denver, Colorado, United States, 80045

Washington

Children's Research Institute, Washington, District of Columbia, United States, 20010

Atlanta

Emory University, Atlanta, Georgia, United States, 30322

Indianapolis

Indiana University Children's Hospital, Indianapolis, Indiana, United States, 47401

Lexington

University of Kentucky, Lexington, Kentucky, United States, 40526

Louisville

Norton Children's Hospital, Louisville, Kentucky, United States, 40202

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * (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
  • 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

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Calgary,

Stephen Freedman, MDCM, PRINCIPAL_INVESTIGATOR, University of Calgary

Study Record Dates

2027-08-31