Hyperhydration in Children With Shiga Toxin-Producing E. Coli Infection
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age9-21
SponsorUniversity of Calgary
About this trial
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 criteria
Qualifiers
Aged 9.0 months to <21 years at the time of informed consent.
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
Disqualifiers
Hematocrit <30% AND
Platelet count <150 x 103/mm3 AND
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.
Trial design
Treatments tested in this trial
- Infusion of 200% maintenance fluids as balanced crystalloid IV solution
- Oral fluids; infusion of up to 110% maintenance fluids as balanced crystalloid IV solution
Treatment groups
1,040 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Calgary
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator
Children's Hospital Medical Center, Cincinnati
Collaborator
Washington University School of Medicine
Collaborator
University of Utah
Collaborator
Seattle Children's Hospital
Collaborator
University of Colorado, Denver
Collaborator
Emory University
Collaborator
University of California, Davis
Collaborator
Baylor College of Medicine
Collaborator
Indiana University
Collaborator
University of Alabama at Birmingham
Collaborator
Arkansas Children's Hospital Research Institute
Collaborator
Children's National Research Institute
Collaborator
Children's Hospitals and Clinics of Minnesota
Collaborator
Medical University of South Carolina
Collaborator
University of Louisville
Collaborator
University of Oklahoma
Collaborator
Oregon Health and Science University
Collaborator
University of California, San Diego
Collaborator
McMaster University
Collaborator
The Hospital for Sick Children
Collaborator
University of Alberta
Collaborator
University of Kentucky
Collaborator
Case Western Reserve University
Collaborator
Nationwide Children's Hospital
Collaborator
Vanderbilt University Medical Center
Collaborator
Source ClinicalTrials.gov