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

Who is this study for? Children with shiga toxin-producing E. coli infection
What treatments are being studied? Balanced crystalloid IV solution
Status: Recruiting
Location: See all (26) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 9 months
Maximum Age: 21
Healthy Volunteers: f
View:

⁃ 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

Locations
United States
Alabama
University of Alabama at Birmingham
RECRUITING
Birmingham
Arkansas
Arkansas Children's Hospital
RECRUITING
Little Rock
California
University of California, San Diego
RECRUITING
La Jolla
University of California, Davis
RECRUITING
Sacramento
Colorado
University of Colorado Denver
RECRUITING
Denver
Washington, D.c.
Children's Research Institute
RECRUITING
Washington D.c.
Georgia
Emory University
RECRUITING
Atlanta
Indiana
Indiana University Children's Hospital
RECRUITING
Indianapolis
Kentucky
University of Kentucky
RECRUITING
Lexington
Norton Children's Hospital
RECRUITING
Louisville
Minnesota
Children's Minnesota Hospital
RECRUITING
Minneapolis
Missouri
Washington University
RECRUITING
St Louis
Ohio
Children's Hospital Medical Center
RECRUITING
Cincinnati
University Hospitals Rainbow Babies & Children's Hospital
RECRUITING
Cleveland
Nationwide Children's Hospital
RECRUITING
Columbus
Oklahoma
University of Oklahoma Health Sciences Center
RECRUITING
Oklahoma City
Oregon
Oregon Health & Science University
RECRUITING
Portland
South Carolina
Medical University of South Carolina
RECRUITING
Charleston
Tennessee
Vanderbilt Children's Hospital
RECRUITING
Nashville
Texas
Baylor College of Medicine
RECRUITING
Houston
Utah
University of Utah
RECRUITING
Salt Lake City
Washington
Seattle Children's Hospital
RECRUITING
Seattle
Other Locations
Canada
Alberta Children's Hospital
RECRUITING
Calgary
University of Alberta
RECRUITING
Edmonton
McMaster University
RECRUITING
Hamilton
The Hospital for Sick Children
RECRUITING
Toronto
Contact Information
Primary
Study Manager
hikostec@hsc.utah.edu
(801) 581-6410
Time Frame
Start Date: 2022-09-29
Estimated Completion Date: 2027-08-31
Participants
Target number of participants: 1040
Treatments
Experimental: Hyperhydration
In this study arm, all eligible children are admitted for the administration of intravenous fluids.~The following specifics will form the basis of the fluid management protocol:~1. Reversal of dehydration: Initial ED rehydration strategies should focus on rapidly reversing dehydration.~2. Infusion of 200% of maintenance fluids x 24 hours~3. If hematocrit reduction \< 20% from initial value, repeat step #2 \[infusion of 200% maintenance fluids x 24 hours\].~4. Oral fluids permitted ad lib.~5. Once the target hematocrit reduction is achieved (20% decrement in initial HCT) AND a 10% weight gain, adjust total IV fluid volume to maintain targeted weight gain: insensible plus output (i.e., urine plus stool).
Active_comparator: Conservative Fluid Management
The conservative fluid management arm has been designed to align and integrate into existing local practice patterns. Implementation of this approach will allow institutions and their practitioners to choose their management of protocol eligible children. All children will undergo a protocolized baseline evaluation that includes reversal of dehydration (if present) and follow-up plan (see Pre-Pathway care). The fluid management decision in the ED (i.e., to treat dehydration) will be at the discretion of the clinical care team. In the absence of evidence of microangiopathy (i.e., normal urinalysis, LDH, hemoglobin and platelet counts, and creatinine concentrations), the decision to admit the child to hospital or discharge the child to home will be at the discretion of the clinical care team. If microangiopathy is present (i.e., abnormal urinalysis, LDH, hemoglobin or platelet counts, or creatinine concentrations) admission for monitoring will be required.
Sponsors
Collaborators: Washington University School of Medicine, Medical University of South Carolina, University of California, San Diego, Emory University, Nationwide Children's Hospital, Vanderbilt University Medical Center, Children's Hospitals and Clinics of Minnesota, Seattle Children's Hospital, University of Louisville, Children's Hospital Medical Center, Cincinnati, Oregon Health and Science University, University of Oklahoma, Indiana University School of Medicine, Case Western Reserve University, Arkansas Children's Hospital Research Institute, National Institute of Allergy and Infectious Diseases (NIAID), Children's National Research Institute, University of Kentucky, University of Alberta, University of Utah, University of Alabama at Birmingham, University of California, Davis, Baylor College of Medicine, University of Colorado, Denver, McMaster University, The Hospital for Sick Children
Leads: University of Calgary

This content was sourced from clinicaltrials.gov

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