RECRUITING

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

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Conditions

Shiga Toxin-Producing Escherichia Coli (E. Coli) InfectionHemolytic-Uremic SyndromeChildHemolytic Uremic SyndromeShiga-Toxigenic Escherichia coliRenal Replacement TherapyAcute Kidney InjuryAmbulatory CareEmergency Department

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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

Quick Facts

Study Start:2022-09-29
Study Completion:2027-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05219110

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.

Ages Eligible for Study:9 Months to 21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Aged 9.0 months to \<21 years at the time of informed consent.
  2. 2. Evidence of high-risk STEC infecting pathogen defined by any of the following:
  3. 1. Bloody diarrhea within the preceding 7 days
  4. * Positive STEC culture OR
  5. * Positive antigen/polymerase chain reaction test for toxin/gene type not otherwise specified OR
  6. 2. Bloody or Non-bloody diarrhea within the preceding 7 days
  7. * (meeting all 3 HUS criteria - anemia, thrombocytopenia, and renal insufficiency) OR
  8. 3. Non-bloody or no diarrhea
  9. * Positive STEC culture for high-risk strain (i.e., O103, O104, O111, O113, O121, O145 or O157) OR
  10. * Positive antigen/polymerase chain reaction test Stx2 toxin/gene
  1. 1. Presence of Advanced HUS defined by:
  2. 1. Hematocrit \<30% AND
  3. 2. Platelet count \<150 x 103/mm3 AND
  4. 3. Creatinine \> 2.0 mg/dL (177 µmol/L)
  5. * 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.
  6. 2. Prior episode of HUS or diagnosis of atypical HUS.
  7. 3. Chronic disease limiting fluid volumes administered (e.g. impaired renal, liver, or cardiac function, chronic lung disease).
  8. 4. Evidence of anuria (i.e., no urine output for \> 24 hours).
  9. 5. Hypoxemia requiring oxygen therapy
  10. 6. Hypertensive emergency
  11. 7. Greater than or equal to 10 days since onset of diarrhea or if no diarrhea then the onset of other symptoms.
  12. 8. Patients with known pregnancy
  13. 9. Patients or caregivers with language barriers impairing appropriate conduct of the study protocol.

Contacts and Locations

Study Contact

Study Manager
CONTACT
(801) 581-6410
hikostec@hsc.utah.edu

Principal Investigator

Stephen Freedman, MDCM
PRINCIPAL_INVESTIGATOR
University of Calgary

Study Locations (Sites)

University of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
United States
University of California, San Diego
La Jolla, California, 92093
United States
University of California, Davis
Sacramento, California, 95817
United States
University of Colorado Denver
Denver, Colorado, 80045
United States
Children's Research Institute
Washington, District of Columbia, 20010
United States
Emory University
Atlanta, Georgia, 30322
United States
Indiana University Children's Hospital
Indianapolis, Indiana, 47401
United States
University of Kentucky
Lexington, Kentucky, 40526
United States
Norton Children's Hospital
Louisville, Kentucky, 40202
United States
Children's Minnesota Hospital
Minneapolis, Minnesota, 55404
United States
Washington University
Saint Louis, Missouri, 63110
United States
Children's Hospital Medical Center
Cincinnati, Ohio, 45229-3039
United States
University Hospitals Rainbow Babies & Children's Hospital
Cleveland, Ohio, 44106
United States
Nationwide Children's Hospital
Columbus, Ohio, 43205
United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
United States
Oregon Health & Science University
Portland, Oregon, 97239
United States
Medical University of South Carolina
Charleston, South Carolina, 29425
United States
Vanderbilt Children's Hospital
Nashville, Tennessee, 43205
United States
Baylor College of Medicine
Houston, Texas, 77030
United States
University of Utah
Salt Lake City, Utah, 84112
United States
Seattle Children's Hospital
Seattle, Washington, 98105
United States

Collaborators and Investigators

Sponsor: University of Calgary

  • Stephen Freedman, MDCM, PRINCIPAL_INVESTIGATOR, University of Calgary

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

Study Start Date2022-09-29
Study Completion Date2027-08-31

Study Record Updates

Study Start Date2022-09-29
Study Completion Date2027-08-31

Terms related to this study

Keywords Provided by Researchers

  • Child
  • Hemolytic Uremic Syndrome
  • Shiga-Toxigenic Escherichia coli
  • Renal Replacement Therapy
  • Acute Kidney Injury
  • Ambulatory Care
  • Emergency Department

Additional Relevant MeSH Terms

  • Shiga Toxin-Producing Escherichia Coli (E. Coli) Infection
  • Hemolytic-Uremic Syndrome